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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
October 2, 2023
TREVENA, INC.
(Exact name of registrant as specified in
its charter)
Delaware
(State or other jurisdiction of incorporation)
001-36193 |
|
26-1469215 |
(Commission File No.) |
|
(IRS Employer Identification No.) |
955 Chesterbrook Boulevard, Suite 110
Chesterbrook, PA 19087
(Address of principal executive offices and zip
code)
Registrant’s telephone number, including
area code: (610) 354-8840
Not applicable
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section
12(b) of the Act:
Title of each class | |
Trading Symbol(s) | |
Name of each exchange on which registered |
Common Stock, $0.001 par value | |
TRVN | |
The Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company
¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 7.01 |
Regulation FD Disclosure |
On October 2, 2023, Trevena,
Inc. (the “Company”) updated its website to include an updated corporate presentation deck. A copy of the updated corporate
deck is attached hereto as Exhibit 99.1.
The information set forth
on this Item 7.01 and furnished hereto as Exhibits 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s
filings under the Securities Act of 1933, as amended (the “Securities Act”) or the Exchange Act, whether made before or after
the date hereof, except as shall be expressly set forth by specific reference in any such filing.
On October 2, 2023, the Company issued a press release announcing
completion of the initial analysis of the OLINVYK continuous respiratory monitoring data from the VOLITION study and presentation of the
data at the American Society of Anesthesiologists. A copy of the press release is furnished hereto as Exhibit 99.2 and incorporated herein
by reference.
The information set forth in this Item 8.01 and furnished hereto as
Exhibit 99.2 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or incorporated by reference in any
filing under the Securities Act or the Exchange Act, whether made before or after the date of this Current Report, except as shall be
expressly set forth by specific reference in such a filing.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
SIGNATURES
Pursuant to the requirements of the Exchange Act,
the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
TREVENA, INC. |
|
|
Date: October 2, 2023 |
By: |
/s/ Barry Shin |
|
|
Barry Shin |
|
|
Senior Vice President & Chief Financial Officer |
Exhibit 99.1 | INNOVATING FOR PATIENTS
Nasdaq: TRVN I October 2023 |
| Forward-Looking Statements
To the extent that statements contained in this presentation are not descriptions of historical facts regarding Trevena, Inc. (the “Company” or “we”), they are forward-looking statements
reflecting management’s current beliefs and expectations. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our
industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. You can identify forward-looking statements by
terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “objective,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,”
“continue,” “ongoing,” or the negative of these terms or similar expressions. Forward-looking statements contained in this presentation include, but are not limited to, (i) statements regarding
the timing of anticipated clinical trials for our product candidates; (ii) the timing of receipt of clinical data for our product candidates; (iii) our expectations regarding the potential safety, efficacy,
or clinical utility of our product candidates; (iv) the size of patient populations targeted by our product candidates and market adoption of our potential drugs by physicians and patients; (v) the
timing or likelihood of regulatory filings and approvals; and (vi) our cash needs.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the commercialization of any approved drug
product, the status, timing, costs, results and interpretation of our clinical trials or any future trials of any of our investigational drug candidates; the uncertainties inherent in conducting clinical
trials; expectations for regulatory interactions, submissions and approvals, including our assessment of the discussions with the FDA or other regulatory agencies about any and all of our
programs; uncertainties related to the commercialization of OLINVYK; available funding; uncertainties related to our intellectual property; other matters that could affect the availability or
commercial potential of our therapeutic candidates; and other factors discussed in the Risk Factors set forth in our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with
the Securities and Exchange Commission (SEC) and in other filings we make with the SEC from time to time. In addition, the forward-looking statements included in this presentation
represent our views only as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these
forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, except as may be required by law.
2 |
| BOARD OF DIRECTORS
Leon O. Moulder, Jr. Chairman Marvin H. Johnson, Jr.
Carrie L. Bourdow Jake R. Nunn
Scott Braunstein, M.D. Anne M. Phillips, M.D.
Mark Corrigan, M.D. Barbara Yanni
SENIOR MANAGEMENT
Carrie L. Bourdow President & Chief Executive Officer
Mark A. Demitrack, M.D. SVP, Chief Medical Officer
Patricia Drake SVP, Chief Commercial Officer
Barry Shin SVP, Chief Financial Officer
Robert T. Yoder SVP, Chief Business Officer & Head
of Commercial Operations
Trevena’s Experienced Leadership Team
3 |
| *OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom
alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation.
Full Prescribing Information at www.OLINVYK.com
NCE = New Chemical Entity; PoC = Proof of concept
Trevena: Innovative CNS Company
4
IV OLINVYK:
Differentiated profile
TRV045:
Selective S1PR modulator
Novel
CNS pipeline
TRV045:
Compelling PoC Data
Financial position
NCE approved for the management of acute pain in adults*
Significant cost savings / differentiation shown in ‘real world’ post-approval studies
S1PR: Validated target for blockbusters (fingolimod / siponimod / ozanimod / ponesimod)
TRV045: Unique profile ( with potential for no lymphopenia) for new indications
New mechanisms for acute / neuropathic pain, epilepsy, acute migraine, opioid use disorder
NCEs targeting significant unmet needs
Statistically significant, dose-dependent effect in validated model of neuropathic pain
Statistically significant EEG changes and evidence of early reduction in cortical excitability
$28.1M cash / equivalents / marketable securities @ 2Q 23
$15M non-dilutive tranche received 3Q 23 (ex-US royalty based financing) |
| *OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom
alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation.
Full Prescribing Information at www.OLINVYK.com
TRV045 and TRV734 are investigational products and are not approved by the FDA or any other regulatory agency
NDA = New Drug Application; PoC = Proof-of-Concept
PRE-CLIN PHASE 1 PHASE 2 PHASE 3 NDA POST-APPR Highlights
OLINVYK®
New chemical entity
(mu-opioid receptor)
TRV045
Selective S1P
receptor modulator
• Data reported
• Data reported
• Data expected 2H 23
• Data expected 2H 23
TRV734
G-protein selective agonist
(mu-opioid receptor)
Multiple Expected Catalysts
5
NIH / NIDA collab.
IV acute pain*
VOLITION clinical outcomes
Respiratory physiology
Cleveland Clinic / Wake Forest Baptist Health collab.
PoC – pain / target engagement
PoC - epilepsy
APPROVED
• Real world differentiation
• Data reported
• Commercial launch ongoing
• POC study ongoing
ARTEMIS clinical outcomes • $8.8k / 1.4 day savings
Opioid use disorder
Seiz. Prev
Inf. Spasm
NIH / ETSP investigating potential disease modifying role
Investigating potential in rare pediatric disorder
Cognitive function
Cleveland Clinic / Wake Forest Baptist Health collab.
• Data reported |
| OLINVYK Overview |
| Large Market Opportunity – Acute Pain
7
45M patients receive IV opioids
annually to treat acute pain1
IV opioids have unrivalled
analgesic efficacy
Top surgeries:
Total knee arthroplasty,
colectomy, hernia repair,
spine fusion, C-section2
IV NSAIDS / acetaminophen
US injectable analgesic
hospital market unit volume1
IV opioids
45%
IV Opioids
17%
38%
Local anesthetics
*OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom
alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation.
Full Prescribing Information at www.OLINVYK.com. Opioids are associated with serious, potentially life-threatening adverse reactions.
NSAIDs = nonsteroidal anti-inflammatory drugs. 1) IMS MIDAS sales audit 2017; IV NSAIDs and Ofirmev®. 2) Definitive database, and
National Vital Statistics report, CDC 2018. |
| OLINVYK: Differentiated Profile for Acute Pain
8
OLINVYK is indicated in adults for the management of acute pain
severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate
Please see Important Safety Information including BOXED WARNING at the end of presentation.
Full Prescribing Information at www.OLINVYK.com.
New chemical entity
Distinct from IV morphine
IV opioid efficacy
Hard- and soft-tissue surgeries
Rapid analgesia
1-3 min median onset of pain relief
Simplified, predictable dosing
No adjustment in renal impaired
No active metabolites
Data in complex patients
Elderly / obese, multiple comorbidities
Well-characterized safety / tolerability
Studied in over 1,900 individuals |
| VOLITION Clinical Outcomes Study w/ Cleveland Clinic
• Open-label, multi-site study led by experts at Cleveland Clinic and Wake Forest Baptist Health
• N = 203 adults undergoing major non-cardiac surgery treated with IV OLINVYK
Further characterizes respiratory, GI and cognitive outcomes
Cognitive Function
90%+
alert / calm at all points3
<4% symptoms of delirium4
3 Richmond Agitation-Sedation Scale 4 3D-CAM screening tool
As reflected in the OLINVYK label, nausea and vomiting were two of the most common AEs reported in the controlled clinical trials
As with all opioids, serious, life-threatening, or fatal respiratory depression may occur in patients treated with OLINVYK
Sedation is an established risk of opioids including OLINVYK
Please see Important Safety Information including BOXED WARNING at the end of presentation
Full Prescribing Information at www.OLINVYK.com
GI Tolerability
52.7%
complete GI response1
defined as no vomiting /
no antiemetic use
through study period
1 In pooled Phase 3 data for OLINVYK, GI complete response
rate was 46.2% (0.35mg) and 39.7% (0.5mg)
Respiratory Outcomes
22.8% respiratory compromise
defined as any one of five
respiratory events2 over
48hrs of continuous monitoring
2 End-tidal PCO2 ≤ 15 mmHg for ≥3 min; RR ≤ 5 breaths/min
for ≥3 min; SpO2 ≤ 85% for ≥3 min; apnea episode >30 sec;
any serious respiratory event |
| ARTEMIS EMR-Based Clinical Outcomes Study
• 201 OLINVYK-treated patients at Cleveland Clinic and Wake Forest Baptist Health VOLITION sites
• 982 matched patients undergoing similar surgical procedures, treated with other IV opioids, at same sites during VOLITION study
10
Statistically significant differentiation on a range of meaningful endpoints
Matched Patients
Treated w/ other IV Opioids
(N=982)
OLINVYK-Treated
VOLITION Patients
(N=201)
Cost per Admission (avg) $45.9k $37.1k P<0.0001
Hospital Length of Stay (avg) 7.1 days 5.7 days P<0.0001
$8.8k savings
1.4 days shorter
24hr mean score 4.5 3.9 P<0.0001
48hr mean score 4.3 3.7 P<0.0001
15.0% lower score
14.8% lower score
Numerical Pain Score (1-10)
As with all opioids, addiction, abuse and misuse, which can lead to overdose and death may occur in patients
treated with OLINVYK as indicated in the boxed warning
EMR analysis does not provide definitive data of group differences as seen in a prospectively randomized study
Please see Important Safety Information including BOXED WARNING at the end of presentation
Full Prescribing Information at www.OLINVYK.com |
| OLINVYK: Ease of Dosing and Administration
• Bolus Dosing: 1 mg and 2 mg vials (single dose)
• PCA Dosing: 30 mg vial (single patient use)
• OLINVYK 1 mg ≈ morphine 5 mg1
27 mg cumulative daily dose limit
Do not administer single doses greater than 3 mg
11
3 vials allow for flexible and tailored IV dosing
No refrigeration / reconstitution
WAC: $17.50 $25.75 $110.00
1 mg / 1mL 2 mg / 2mL 30 mg / 30 mL
~$100 / day
(estimated avg cost across procedures)
Please see Important Safety Information including BOXED WARNING at the end of presentation. Full
Prescribing Information at www.OLINVYK.com.
1) For an initial dose. PCA = Patient-Controlled Analgesia |
| OLINVYK vs IV Morphine Health Economic Models
12
Published1 and available to formulary committees
* As stated in the label these data are not an adequate basis for comparison of rates between OLINVYK treatment group and the morphine
treatment group. The OLINVYK and morphine dosing regimens studied are not considered equipotent.
1) Simpson KN, et al., J Comp Eff Res, 2021; 10:1107-1119 and Simpson KN, et al. Expert Rev Pharmacoecon Outcomes Res; 2022
2) Oderda, GM, J Pain Palliative Care Pharm, 2019; data based on 5 surgical procedure categories including Cardiothoracic / vascular, General / Colorectal, Ob / Gyn, Orthopedic, and
Urologic. 3) Overdyk FJ, PLoS One, 2016. More conservative inputs were used in the model. 4) Calculated based on total costs of Tx and average total costs of care. Image: flaticon.com.
Vomiting
Somnolence / sedation
O2 saturation <90%
Representative Inputs:
>10x
Cost savings
for hospitals4
Due to improved
patient outcomes
HECON
model
Placebo
(N = 162)
OLINVYK ≤ 27 mg
(N = 316)
Morphine
(N = 158)
73 86 96
35 52 70
10 26 52
30 26 30
11 18 25
9 14 14
3 12 17
6 9 19
5 7 13
4 6 10
4 6 6
4 4 8
1 2 10
AE rates*
Cost of AEs
Drug cost
Ph3 trials
Gov’t sources /
Publications
$8k nausea / vomiting2
$28k critical resp event3
+7 days hospital stay3
OLINVYK
IV morphine
Key Outputs: |
| OLINVYK: Significant Opportunity in Acute Pain Market
13
Please see Important Safety Information including BOXED WARNING at the end of presentation. Full Prescribing Information
at www.OLINVYK.com. Source: Definitive Healthcare; American Hospital Association. *Assumes ~$100 / day price for OLINVYK
2032 composition of matter patent expiration does not include potential patent extensions.
Specialty Targets
Patient & Procedure Risk
Initial launch
focus
~45M
patients
Initial core focus:
(9M)
Expanded areas of focus:
(28M)
• Ambulatory surgical centers
• Hospitals
Core focus
~15M days of therapy (initial focus)
=
$1.5B+ market opportunity*
• New cognitive function / respiratory / GI data versus IV morphine
• Additional HECON data focused on recovery time
Expanded areas of focus
2032+
COM Patent |
| TRV045
S1P Receptor Modulator
Novel MOA for Diabetic Neuropathic Pain |
| Epilepsy
• Neuroprotective effects3
• Modulates BBB permeability,
anti-inflammatory effects4,5
Neuropathic pain
• Inhibits pain sensation1
• Inhibits excitatory neuronal signaling2
S1P1 Receptor – Novel Target for CNS Indications
1) Sim-Selley et al., Journal of Pharmacology & Experimental Therapeutics, 2018. 2) Sim-Selley et al, Journal of Neurochemistry, 2008. 3) Gol et al., European Journal of
Pharmaceutical Sciences, 2017. 4) Leo et al, CNS & Neurological Disorders - Drug Targets, 2017. 5) Choi, et al. PNAS 2011.
S1P1 receptors are highly expressed on key CNS cells involved in neuroinflammation
Potential therapeutic role in seizures, epileptogenesis and pain signaling
Existing S1PR-targeted drugs, however, are ill-suited for CNS indications due to known:
Lymphopenia Pulmonary AEs
Cardiac AEs Ophthalmologic AEs
15 |
| TRV045 MOA: Rapid Receptor Recycling
β-arrestin2
S1P1 receptor
Gβγ GRK
↑I Internalization KAch
ligand
Gαi
↓cAMP
↓ Ca++
(via IcaL)
Reduces surface receptor,
which leads to lymphopenia
(Gilenya, etc)
Receptor Recycling
Maintains surface receptor and
avoids lymphopenia, allowing free
lymphocyte egress into circulation
Receptor Degradation
Other S1PR Drugs TRV045
16
Maintained (rather than degraded) S1P receptors on cell surface
No lymphopenia
reported in prior
Phase 1 FIH study
Maintained surface receptor,
allowing free lymphocyte egress
into circulation
FIH = First in human
Source: Trevena data on file |
| 0
1
2
3
4
5
6
Fingolimod TRV045
No Lymphopenia
TRV045 Efficacy in Nonclinical Chronic Pain Models (w/ no
Lymphopenia)
1) CIPN mouse model: Paclitaxel 6 mg/kg, i.p. on Days 1, 3, 5, 7. Hyperalgesia measured as % non-response to 0.4 g Von Frey filament vs. baseline, tested 30’ after dosing on Day 13.
Lymphocytes measured after 3 days of dosing. Data are mean ± s.e.m. n=5-7 mice/group. *p<0.05 or **p<0.01 vs. control
peripheral lymphocytes
(103 cells /
µL)
0.03 mg/kg po 3.7 mg/kg sc
Vehicle
alone
No
reduction
despite 3.7x
dosing
(vs. above)
**
Reversed Pain Response
0
20
40
60
80
100
Fingolimod TRV045
% non-response
to pain stimulus
0.03 mg/kg po 1.0 mg/kg sc
Paclitaxel- induced
hyperalgesia
*
**
17
Mouse chemotherapy-induced peripheral neuropathy (CIPN) model
Reversed neuropathic pain…
…with no lymphopenia
Source: Trevena data on file |
| TRV045 Demonstrates Efficacy in Nonclinical Epilepsy Models
• NIH-supported Epilepsy Therapy Screening Program
• Acute seizure protection in max. electroshock model
- Replicated in 3 independent experiments using either
subcutaneous or oral administration
• Efficacy demonstrated in two different preclinical
models of epilepsy (data shown at right)
- Corneal-kindled seizure model (SC, PO)
• Dose-dependent protection in seizure risk across
two studies
- Post-kainite spontaneous recurrent seizure model (IP*)
• Dose-dependent reduction in seizure burden and
increase in seizure freedom endpoints across two
studies
B ase line Ve hicle T RV045
0
4
8
1 2
1 6
2 0
Seizure B urden S core
*
B ase line Ve hicle T RV045
0
4
8
1 2
1 6
2 0
Seizure B urden S core
*
* p<0.05 v vehicle, ** p<0.05 v baseline; Wilcoxon rank sum
# p<0.05 v baseline and vehicle; Fisher’s exact test
Corneal kindled mouse
Subcutaneous
Corneal kindled mouse
Oral
Post-kainite rat (IP)
10 mg/kg
Post-kainite rat (IP)
15 mg/kg
0
20
40
60
80
100
1 2.5 5 7.5 10
0
20
40
60
80
100
1 2.5 10 15 20
% protected
% protected
TRV045 mg/kg TRV045 mg/kg
Data on file, Trevena, Inc., 2022; * IP = intraperitoneal
**
*
#
0
25
50
75
% Seizure Freedom
Baseline Vehicle TRV045 0
25
50
75
% Seizure Freedom
Baseline Vehicle TRV045 |
| TRV045 Phase 1 Study – Safety / Tolerability / PK
Randomized, double-blinded, placebo-controlled study
3-parts: single dose (n=53), food effect (n=27), multiple dose (n=9)
19
Well Tolerated • Favorable tolerability profile with no SAEs
Target
Exposure
Attractive PK
Profile
• Calculated free plasma concentrations exceeded targeted efficacy range1
• Half-life consistent with anticipated once-daily dosing
Targeted CNS proof-of-concept study initiated
Highly
Differentiated
• No lymphopenia and no reported cardiac / pulmonary / ophthalmologic AEs
(AEs commonly associated with currently marketed S1P-targeted compounds)
1 Based on nonclinical measures of in vitro and in vivo PD |
| Studies were conducted outside the United States and not under the IND for TRV045
POC Studies: Target Engagement / TMS
20
Results confirm activity of central action and
support advancement for neuropathic pain and other CNS indications
Target Engagement Study
Randomized, double-blind, placebo-controlled, 4x cross-over
(n=25 subjects)
Placebo or TRV045
(50/150/300mg)
PainCart endpoints
TMS Study
Randomized, double-blind, placebo-controlled, multiple dose, 2x cross-over
(n=25 subjects)
Placebo or TRV045
(250mg / four days)
EMG / EEG endpoints |
| TE Study: Significantly Reduced Mechanical Allodynia
21
1% capsaicin-treated dominant volar forearm – Von Frey filament allodynic area (CFB, mm2) Change from Baseline (mm2)
-1200
-1000
-800
-600
-400
-200
0
200
400
600
Baseline Hr 1 Hr 2 Hr 4 Hr 6 Hr 8 Hr 10
Total Allodynic Area
Placebo
50mg
150mg
300mg
-1200
-1000
-800
-600
-400
-200
0
200
400
600
Baseline Hr 1 Hr 2 Hr 4 Hr 6 Hr 8 Hr 10
Secondary Allodynic Area
Placebo
50mg
150mg
300mg
300mg TRV045 v Placebo; P=0.0023
150mg TRV045 v Placebo; P=0.0022
300mg TRV045 v Placebo; P=0.0001
150mg TRV045 v Placebo; P=0.0002
Source: Trevena data on file |
| TMS Study: Effect on Brain Wave Activity
-5
0
5
10
Delta Theta Alpha Beta Gamma
TRV045 Placebo
22
Resting qEEG Power Spectral Analysis – Eyes Open, Day 4 TRV045 v Placebo All Bands
-5
0
5
10
Delta Theta Alpha Beta Gamma
TRV045 Placebo
-5
0
5
10
Delta Theta Alpha Beta Gamma
TRV045 Placebo
*
*
*
* *
* +21.3% -15.2%
+23.1%
+40.7%
+38.8%
+26.6%
(µ
V
2) CFB (µ
V
2) CFB
(µ
V
2) CFB
Frontal*
Left Parietal*
Right Parietal*
Alpha: Significant increase across all regions
Beta/Gamma: Significant increase in frontal region
Delta: Significant reduction in right parietal region
Theta: No significant difference
associated with
alertness / arousal
memory / learning
associated with
sedation / sleep
Mantini, D, et al. PNAS (2007); Beste, C, et al. Nature Comm Biol (2023);
Edwards, DJ and Trujillo, LT, Brain Sci (2021); Holler, Y, et al., CNS Drugs (2018)
* Denotes pairwise comparison P < 0.05
Frontal = Fz-Cz; left parietal = Pz-O1; right parietal = PzO2
CFB = change from baseline; Source: Trevena data on file |
| TMS Study: Effect on Cortical Excitability vs AEDs*
Mean change from baseline in MEP on Day 1 with TRV045 comparable in magnitude to MEP reductions seen
with known AEDs, including levetiracetam, valproic acid, and lorazepam, performed in the same laboratory
23
Mean change from baseline in motor-evoked potential (MEP) measured by peak-to-peak amplitude
Ruijs, TQ, et al. BJCP (2022) 88:2926-2937
Estimated difference vs placebo:
• Levetiracetam: -378.4 µV, 95% CI -644.3 to -112.5; P<0.01
• Valproic acid: -268.8 µV, 95% CI -532.9 to -4.6; P=0.047
• Lorazepam: -330.7.4 µV, 95% CI -595.6 to -65.8; P=0.02
782.0
840.1 859.0
605.4
0
100
200
300
400
500
600
700
800
900
1000
Placebo Day 1 TRV045 Day 1
Mean Peak Amplitude (
µV)
Pre-dose
4h post-dose
Est. difference TRV045 v placebo (not stat. sig.)
• -304.14 µV, 95% CI -688.19 to 79.919 (P=0.1182)
* AEDs = Antiepileptic drugs
Source: Trevena data on file |
| Overall TRV045 POC Study Conclusions
• Target Engagement. Demonstrated CNS penetration and target engagement
• Neuropathic Pain. Statistically significant, dose-dependent effect in validated model of neuropathic pain
• EEG Spectral Power. Statistically significant increases in brain waves (alpha, beta, gamma) associated
with arousal, alertness, cognitive processing, learning and memory
Statistically significant decrease in delta brain waves, and no significant change in
theta brain waves, which are both associated with sedation / sleep
• Cortical Excitability. Promising evidence of early reduction in cortical excitability
TRV045 Proof-of-Concept Study Program
Taken together, these two POC studies provide
strong support and direction for future development of TRV045 |
| TRV734: Maintenance Therapy for
Opioid Use Disorder |
| TRV734: Maintenance Therapy for Opioid Use Disorder
26
Selective agonism at µ receptor: nonclinical evidence of improved tolerability
1) Center for Behavioral Health Statistics and Quality. 2) NIDA data on file.
Ongoing collaboration with National Institute
on Drug Abuse (NIDA)
>2.5M
people in
U.S. suffer from
opioid use disorder1
NIDA study demonstrated reduced drug-seeking
behavior in animal model of relapse2
NIDA-funded proof-of-concept patient study
initiated
• Randomized, double-blind, placebo- and positive-controlled study
• N = ~50 opioid-dependent patients undergoing stable methadone
maintenance therapy
• Primary endpoint: suppression of withdrawal symptoms as
measured by the Subjective Opioid Withdrawal Scale
• Secondary outcomes: assessments of safety, tolerability, and
neurocognitive changes |
| *OLINVYK is indicated in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom
alternative treatments are inadequate. Please see Important Safety Information including BOXED WARNING at the end of presentation.
Full Prescribing Information at www.OLINVYK.com
NCE = New Chemical Entity; PoC = Proof of concept
Trevena: Innovative CNS Company
27
IV OLINVYK:
Differentiated profile
TRV045:
Selective S1PR modulator
Novel
CNS pipeline
TRV045:
Compelling PoC Data
Financial position
NCE approved for the management of acute pain in adults*
Significant cost savings / differentiation shown in ‘real world’ post-approval studies
S1PR: Validated target for blockbusters (fingolimod / siponimod / ozanimod / ponesimod)
TRV045: Unique profile ( with potential for no lymphopenia) for new indications
New mechanisms for acute / neuropathic pain, epilepsy, acute migraine, opioid use disorder
NCEs targeting significant unmet needs
Statistically significant, dose-dependent effect in validated model of neuropathic pain
Statistically significant EEG changes and evidence of early reduction in cortical excitability
$28.1M cash / equivalents / marketable securities @ 2Q 23
$15M non-dilutive tranche received 3Q 23 (ex-US royalty based financing) |
| 28
IMPORTANT SAFETY INFORMATION |
| WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY
DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM
CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS
SYSTEM (CNS) DEPRESSANTS
Addiction, Abuse, and Misuse
OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and
misuse, which can lead to overdose and death. Assess each patient’s risk before
prescribing OLINVYK, and monitor all patients regularly for the development of
behaviors or conditions.
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK.
Monitor for respiratory depression, especially during initiation of OLINVYK or following a dose
increase.
Neonatal Opioid Withdrawal Syndrome
Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal
syndrome, which may be life-threatening if not recognized and treated, and requires
management according to protocols developed by neonatology experts. If opioid use is required
for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid
withdrawal syndrome and ensure that appropriate treatment will be available.
Risk From Concomitant Use With Benzodiazepines or Other CNS Depressants
Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol,
may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant
prescribing for use in patients for whom alternative treatment options are inadequate; limit
dosages and durations to the minimum required; and follow patients for signs and symptoms of
respiratory depression and sedation.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve OLINVYK
for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination
products]:
• Have not been tolerated, or are not expected to be tolerated
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.
The cumulative total daily dose should not exceed 27 mg, as total daily doses greater than 27 mg may increase the
risk for QTc interval prolongation.
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
• Significant respiratory depression
• Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
• Known or suspected gastrointestinal obstruction, including paralytic ileus
• Known hypersensitivity to oliceridine (e.g., anaphylaxis)
WARNINGS AND PRECAUTIONS
• OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction,
abuse, and misuse. Although the risk of addiction in any individual is unknown, it can occur in patients
appropriately prescribed OLINVYK. Assess risk, counsel, and monitor all patients receiving opioids.
• Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as
recommended, especially in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated
patients. The risk is greatest during initiation of OLINVYK therapy, following a dose increase, or when used
with other drugs that depress respiration. Proper dosing of OLINVYK is essential, especially when converting
patients from another opioid product to avoid overdose. Management of respiratory depression may include
close observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical
status.
• Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related
hypoxemia with risk increasing in a dose-dependent fashion. In patients who present with CSA, consider
decreasing the dose of opioid using best practices for opioid taper.
INDICATIONS AND USAGE
OLINVYK is a new chemical entity indicated in adults for the management of acute pain severe enough to
require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
29 |
| WARNINGS AND PRECAUTIONS
• Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be
life-threatening. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage
accordingly. Advise pregnant women using OLINVYK for a prolonged period of the risk of neonatal
opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Profound sedation, respiratory depression, coma, and death may result from the concomitant use of
OLINVYK with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics,
anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, or alcohol).
Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom
alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration.
• OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were
dosed up to 27 mg. Total cumulative daily doses exceeding 27 mg per day were not studied and may
increase the risk for QTc interval prolongation. Therefore, the cumulative total daily dose of OLINVYK
should not exceed 27 mg.
• Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450
(CYP) 2D6 function or normal metabolizers taking moderate or strong CYP2D6 inhibitors; also in patients
taking a moderate or strong CYP3A4 inhibitor, in patients with decreased CYP2D6 function who are also
receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These
patients may require less frequent dosing and should be closely monitored for respiratory depression and
sedation at frequent intervals. Concomitant use of OLINVYK with CYP3A4 inducers or discontinuation of
a moderate or strong CYP3A4 inhibitor can lower the expected concentration, which may decrease
efficacy, and may require supplemental doses.
• Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month).
Presentation and symptoms may be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness,
dizziness, and low blood pressure. If confirmed, treat with physiologic replacement doses of corticosteroids
and wean patient from the opioid.
• OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory
patients.
• There is increased risk in patients whose ability to maintain blood pressure has already been compromised
by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g.,
phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with
circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac
output and blood pressure.
• Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used
with caution in patients who may be susceptible to the intracranial effects of CO2 retention, such as those
with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the
resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of
sedation and respiratory depression, particularly when initiating therapy.
• As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in
serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening
symptoms.
• There is increased risk in patients whose ability to maintain blood pressure has already been compromised
by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g.,
phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with
circulatory shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac
output and blood pressure.
• Avoid the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used
with caution in patients who may be susceptible to the intracranial effects of CO2 retention, such as those
with evidence of increased intracranial pressure or brain tumors, as a reduction in respiratory drive and the
resultant CO2 retention can further increase intracranial pressure. Monitor such patients for signs of
sedation and respiratory depression, particularly when initiating therapy.
• As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in
serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening
symptoms.
• OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the
risk of seizures in vulnerable patients. Monitor patients with a history of seizure disorders for worsened
seizure control.
• Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Gradually taper the
dosage to avoid a withdrawal syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g.,
pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients
who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal
symptoms.
• OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities
such as driving a car or operating machinery.
• Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to
individually titrate to an acceptable level of analgesia, PCA administration has resulted in adverse
outcomes and episodes of respiratory depression. Health care providers and family members monitoring
patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for excessive
sedation, respiratory depression, or other adverse effects of opioid medications.
ADVERSE REACTIONS
Adverse reactions are described in greater detail in the Prescribing Information.
The most common (incidence ≥10%) adverse reactions in Phase 3 controlled clinical trials were nausea,
vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
PLEASE see www.OLNVYK.com for full prescribing information including BOXED warning and important safety
information
30 |
Exhibit 99.2
Trevena Announces Completion of Initial Analysis
of OLINYVK Continuous Respiratory Monitoring Data from VOLITION Study and Presentation at American Society of Anesthesiologists Conference
Continuous respiratory monitoring data for ~200
complex surgical patients treated with IV OLINVYK at Cleveland Clinic and Wake Forest Baptist Health in the VOLITION study provides insights
into respiratory compromise rates
VOLITION data to be presented at the American
Society of Anesthesiologists Meeting October 13-17, 2023
Company will also participate in the BIO Investor Forum
October 17-18, 2023
CHESTERBROOK, Pa., October 2, 2023 (GLOBE NEWSWIRE) – Trevena, Inc.
(Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central
nervous system (CNS) disorders, today announced completion of initial analysis of OLINVYK continuous respiratory monitoring data from
the VOLITION study.
The VOLITION study, a real-world, open-label, multi-site study, assessed
the potential impact of OLINVYK on respiratory, gastrointestinal (GI), and cognitive function outcomes in the postoperative setting. The
Company previously announced GI and cognition data from the study.
“We are pleased to announce completion
of the initial analysis of respiratory data from the ~200 patient VOLITION study generated at Cleveland Clinic and Wake Forest Baptist
Health,“ said Carrie Bourdow, President and CEO of Trevena. “We are excited to present these new results at the upcoming
ASA meeting in October.”
| · | VOLITION Study Data, Including Continuous Respiratory Monitoring Analysis, to be Presented at ASA in San Francisco
from October 13-17, 2023. The Company has three abstracts accepted for presentation at ASA, which will be held in San
Francisco from October 13-17. One abstract was selected for an oral presentation as a top research abstract. The oral
presentation titled “Antinociception versus
Neurocognitive Effect of Biased mu-Opioid Receptor Oliceridine versus Morphine: Utility Function Analyses” will be part of the
Best of Abstracts: Clinical Science feature session. The abstracts are embargoed until the conclusion of the meeting and at which
time they will be available at https://www.trevena.com/publications. |
| · | Company to Participate in the BIO Investor Forum in San Francisco from October 17-18,
2023. Members of the Trevena management team will be participating in 1x1 meetings and encourage investors to schedule a
time during the conference. |
VOLITION Study Details
VOLITION is a real-world, open-label, multi-site, post-approval clinical
outcomes study in 203 adult patients undergoing major non-cardiac surgery (197 patients with evaluable respiratory data). IV OLINVYK was
dosed as the first-line analgesic during post-operative care, with a 1.5mg loading dose of OLINVYK at surgical closure, and 0.35mg to
0.5mg of OLINVYK, as needed, administered with a PCA device, with a 6-minute lockout period. Additional boluses (≤1 mg) of OLINVYK
were available if needed as soon as 15 minutes after the initial 1.5 mg loading dose.
Patients in the VOLITION study wore a device that continuously monitored
physiologic status including heart rate, respiratory rate and indices of oxygen and expired carbon dioxide, with data from this monitoring
collected in a manner blinded to the clinical staff caring for the patient. The continuous monitoring methods used in the VOLITION study
were modeled after the similar methodology of respiratory depression assessment used in the recently completed PRODIGY study, which itself
was led by clinical outcomes research experts from Wake Forest Baptist Health and the Cleveland Clinic. As in the PRODIGY study, investigators
in the VOLITION study evaluated the proportion of patients meeting an expert adjudicated criterion of meaningful respiratory compromise,
defined by a collapsed composite of any one or more of: 1) end-tidal carbon dioxide <15mmHg for ≥3 minutes; 2) respiratory rate
≤5 breaths/minute for ≥3 minutes; 3) SpO2 ≤ 85% for ≥3 minutes; 4) Apnea episode lasting >30 seconds; 5) any serious respiratory
event. No drug-related serious adverse events (SAEs) and no deaths were reported in the VOLITION study.
The average age of patients in VOLITION was 57.1 years (range 19 to
89), with approximately equal representation of men and women. Approximately 86% of patients underwent an abdominal surgical intervention,
such as partial or total colectomy, enterotomy or other open abdominal procedures. A majority of patients had significant morbidity at
the time of surgery as reflected by ASA status, and their respiratory risk was intermediate to high risk, graded using the PRODIGY risk
score. The average duration of the surgery was 4.8 hours (range of 1.2 to 12.6 hours).
About OLINVYK®
(oliceridine) injection
OLINVYK is a new chemical entity approved by
the FDA in August 2020. OLINVYK contains oliceridine, an opioid, which is a Schedule II controlled substance with a high potential
for abuse similar to other opioids. It is indicated in adults for the management of acute pain severe enough to require an intravenous
opioid analgesic and for whom alternative treatments are inadequate. OLINVYK is available in 1 mg/1 mL and 2 mg/2 mL single-dose vials,
and a 30 mg/30 mL single-patient-use vial for patient-controlled analgesia (PCA). Approved PCA doses are 0.35 mg and 0.5 mg and doses
greater than 3 mg should not be administered. The cumulative daily dose should not exceed 27 mg. Please see Important Safety Information,
including the BOXED WARNING, and full prescribing information at www.OLINVYK.com.
IMPORTANT SAFETY INFORMATION
WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CENTRAL NERVOUS
SYSTEM (CNS) DEPRESSANTS
ADDICTION, ABUSE,
AND MISUSE – OLINVYK exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can
lead to overdose and death. Assess each patient’s risk before prescribing OLINVYK, and monitor all patients regularly for the development
of behaviors or conditions.
LIFE-THREATENING
RESPIRATORY DEPRESSION – Serious, life-threatening, or fatal respiratory depression may occur with use of OLINVYK. Monitor
for respiratory depression, especially during initiation of OLINVYK or following a dose increase.
NEONATAL OPIOID
WITHDRAWAL SYNDROME – Prolonged use of OLINVYK during pregnancy can result in neonatal opioid withdrawal syndrome, which
may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome
and ensure that appropriate treatment will be available.
RISK FROM CONCOMITANT
USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS – Concomitant use of opioids with benzodiazepines or other CNS depressants,
including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in
patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients
for signs and symptoms of respiratory depression and sedation.
INDICATIONS AND USAGE
OLINVYK is an opioid agonist indicated in adults for the management
of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments are inadequate.
Limitations of Use
Because of the risks of addiction, abuse, and misuse with opioids,
even at recommended doses, reserve OLINVYK for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or
opioid combination products]:
| · | Have not been tolerated, or are not expected to be tolerated |
| · | Have not provided adequate
analgesia, or are not expected to provide adequate analgesia. The cumulative total daily dose should not exceed 27 mg, as total daily
doses greater than 27 mg may increase the risk for QTc interval prolongation. |
CONTRAINDICATIONS
OLINVYK is contraindicated in patients with:
| · | Significant respiratory depression |
| · | Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment |
| · | Known or suspected gastrointestinal obstruction, including paralytic ileus |
| · | Known hypersensitivity to oliceridine (e.g., anaphylaxis) |
WARNINGS AND PRECAUTIONS
| · | OLINVYK contains oliceridine, a Schedule II controlled substance, that exposes users to the risks of addiction, abuse, and misuse.
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed OLINVYK. Assess risk, counsel,
and monitor all patients receiving opioids. |
| · | Serious, life-threatening respiratory depression has been reported with the use of opioids, even when used as recommended, especially
in patients with chronic pulmonary disease, or in elderly, cachectic and debilitated patients. The risk is greatest during initiation
of OLINVYK therapy, following a dose increase, or when used with other drugs that depress respiration. Proper dosing of OLINVYK is essential,
especially when converting patients from another opioid product to avoid overdose. Management of respiratory depression may include close
observation, supportive measures, and use of opioid antagonists, depending on the patient’s clinical status. |
| · | Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia with risk increasing
in a dose-dependent fashion. In patients who present with CSA, consider decreasing the dose of opioid using best practices for opioid
taper. |
| · | Prolonged use of opioids during pregnancy can result in withdrawal in the neonate that may be life-threatening. Observe newborns for
signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using OLINVYK for a prolonged period of the
risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. |
| · | Profound sedation, respiratory depression, coma, and death may result from the concomitant use of OLINVYK with benzodiazepines or
other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics,
antipsychotics, other opioids, or alcohol). Because of these risks, reserve concomitant prescribing of these drugs for use in patients
for whom alternative treatment options are inadequate, prescribe the lowest effective dose, and minimize the duration. |
| · | OLINVYK was shown to have mild QTc interval prolongation in thorough QT studies where patients were dosed up to 27 mg. Total cumulative
daily doses exceeding 27 mg per day were not studied and may increase the risk for QTc interval prolongation. Therefore, the cumulative
total daily dose of OLINVYK should not exceed 27 mg. |
| · | Increased plasma concentrations of OLINVYK may occur in patients with decreased Cytochrome P450 (CYP) 2D6 function or normal metabolizers
taking moderate or strong CYP2D6 inhibitors; also in patients taking a moderate or strong CYP3A4 inhibitor, in patients with decreased
CYP2D6 function who are also receiving a moderate or strong CYP3A4 inhibitor, or with discontinuation of a CYP3A4 inducer. These patients
may require less frequent dosing and should be closely monitored for respiratory depression and sedation at frequent intervals. Concomitant
use of OLINVYK with CYP3A4 inducers or discontinuation of a moderate or strong CYP3A4 inhibitor can lower the expected concentration,
which may decrease efficacy, and may require supplemental doses. |
| · | Cases of adrenal insufficiency have been reported with opioid use (usually greater than one month). Presentation and symptoms may
be nonspecific and include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If confirmed, treat with
physiologic replacement doses of corticosteroids and wean patient from the opioid. |
| · | OLINVYK may cause severe hypotension, including orthostatic hypotension and syncope in ambulatory patients. There is increased risk
in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration
of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics). Monitor these patients for signs of hypotension. In patients with circulatory
shock, avoid the use of OLINVYK as it may cause vasodilation that can further reduce cardiac output and blood pressure. |
| · | Avoid
the use of OLINVYK in patients with impaired consciousness or coma. OLINVYK should be used
with caution in patients who may be susceptible to the intracranial effects of CO2
retention, such as those with evidence of increased intracranial pressure or brain tumors,
as a reduction in respiratory drive and the resultant CO2
retention can further increase intracranial pressure. Monitor such patients for signs of
sedation and respiratory depression, particularly when initiating therapy. |
| · | As with all opioids, OLINVYK may cause spasm of the sphincter of Oddi, and may cause increases in serum amylase. Monitor patients
with biliary tract disease, including acute pancreatitis, for worsening symptoms. |
| · | OLINVYK may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures in vulnerable
patients. Monitor patients with a history of seizure disorders for worsened seizure control. |
| · | Do not abruptly discontinue OLINVYK in a patient physically dependent on opioids. Gradually taper the dosage to avoid a withdrawal
syndrome and return of pain. Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist
(e.g., buprenorphine) analgesics in patients who are receiving OLINVYK, as they may reduce the analgesic effect and/or precipitate withdrawal
symptoms. |
| · | OLINVYK may impair the mental or physical abilities needed to perform potentially hazardous activities
such as driving a car or operating machinery. |
| · | Although self-administration of opioids by patient-controlled analgesia (PCA) may allow each patient to individually titrate to an
acceptable level of analgesia, PCA administration has resulted in adverse outcomes and episodes of respiratory depression. Health care
providers and family members monitoring patients receiving PCA analgesia should be instructed in the need for appropriate monitoring for
excessive sedation, respiratory depression, or other adverse effects of opioid medications. |
ADVERSE REACTIONS
Adverse reactions are described in greater detail in the Prescribing
Information.
The most common (incidence ≥10%) adverse reactions in Phase 3 controlled
clinical trials were nausea, vomiting, dizziness, headache, constipation, pruritus, and hypoxia.
MEDICAL INFORMATION
For medical inquiries
or to report an adverse event, other safety-related information or product complaints for a company product, please contact the Trevena
Medical Information Contact Center at 1- 844-465-4686 or email MedInfo@Trevena.com.
You are encouraged to report suspected
adverse events of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see Full Prescribing Information, including Boxed Warning.
About Trevena
Trevena, Inc. is a biopharmaceutical
company focused on the development and commercialization of innovative medicines for patients with CNS disorders. The Company has one
approved product in the United States, OLINVYK® (oliceridine) injection, indicated
in adults for the management of acute pain severe enough to require an intravenous opioid analgesic and for whom alternative treatments
are inadequate. The Company’s novel pipeline is based on Nobel Prize winning research and includes three differentiated investigational
drug candidates: TRV045 for diabetic neuropathic pain and epilepsy, TRV250 for the acute treatment of migraine and TRV734 for maintenance
treatment of opioid use disorder.
For more information, please visit www.Trevena.com
Forward-Looking Statements
Any statements in this press release about future
expectations, plans and prospects for the Company, including statements about the Company’s strategy, future operations, clinical
development and trials of its therapeutic candidates, plans for potential future product candidates and other statements containing the
words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,”
“plan,” “predict,” “project,” “suggest,” “target,” “potential,”
“will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute
forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially
from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs,
results and interpretation of the
Company’s clinical trials or any future
trials of any of the Company’s investigational drug candidates; the uncertainties inherent in conducting clinical trials; expectations
for regulatory interactions, submissions and approvals, including the Company’s assessment of discussions with FDA; available funding;
uncertainties related to the Company’s intellectual property; other matters that could affect the availability or commercial potential
of the Company’s therapeutic candidates and approved product; and other factors discussed in the Risk Factors set forth in the Company’s
Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in
other filings the Company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release
represent the Company’s views only as of the date hereof. The Company anticipates that subsequent events and developments may cause
the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in
the future, it specifically disclaims any obligation to do so, except as may be required by law.
For more information, please contact:
Investor Contact:
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
(617) 430-7576
Company Contact:
Bob Yoder
SVP and Chief Business Officer
Trevena, Inc.
(610) 354-8840
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