Rolling NDA submission for zuranolone in MDD
expected to begin in early 2022 and planned to be completed in the
second half of 2022 now supported by data from six positive
clinical studies
An associated NDA submission in PPD expected in
2023; Fast Track designation received for zuranolone in PPD
Progressing seven ongoing and planned studies
across neurology and neuropsychiatry franchises in 2022
Ended 2021 with cash balance of $1.7 billion;
anticipate ending 2022 with a cash balance of approximately $1.3
billion
Cash and cash equivalents, ongoing
collaboration funding, and potential revenue, will support
operations into 2025
Conference call today at 8:00 a.m. ET
Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical
company fearlessly leading the way to create a world with better
brain health, today reported business highlights and financial
results for the fourth quarter and full year ended December 31,
2021.
“2021 was a data rich year marked by important advancements in
multiple disease areas across all of our brain health franchises,”
said Barry Greene, chief executive officer at Sage Therapeutics.
“I’m excited to build on this foundation, especially with the
initiation of the rolling NDA submission for zuranolone in MDD
planned for early this year. We believe the entirety of the
development program to date supports zuranolone’s potential to
address substantial unmet needs in major depressive disorder and
postpartum depression and to be a differentiated treatment option
for people with these brain health disorders.”
Key 2021 Highlights
Positive topline data from the WATERFALL and SHORELINE
Studies announced in 2021 and multiple data presentations
supporting zuranolone efficacy and safety: Along with
collaborator Biogen, Sage announced positive topline data from the
WATERFALL and SHORELINE Studies in 2021. The Companies also
presented multiple datasets from the LANDSCAPE and NEST clinical
development programs that support the potential efficacy and safety
of zuranolone for the treatment of major depressive disorder (MDD)
and postpartum depression (PPD), respectively.
- Positive results were shared from the WATERFALL Study, a Phase
3 placebo-controlled trial that evaluated the efficacy and safety
of zuranolone 50 mg in adults 18 to 64 years of age with MDD.
- Positive results from the open-label SHORELINE Study in MDD
showed the majority of people who responded to an initial
zuranolone 50 mg treatment course received only one treatment and
80% received only 1 or 2 treatment courses during their time in
this year-long study.
- Shionogi presented positive results from a Phase 2 study of
zuranolone in MDD in Japan.
- In clinical trials, zuranolone has consistently demonstrated
rapid and sustained improvements in depressive symptoms, with rapid
onset of significant effect as early as Day 3. Additionally,
zuranolone has demonstrated a consistent and well-tolerated safety
profile across the totality of clinical data to date. There were no
signals for increased suicidal ideation/behavior as measured by the
C-SSRS in the program and no evidence of withdrawal symptoms after
discontinuation of zuranolone as assessed by the PWC-20 across the
program.
Including the CORAL Study, zuranolone now has six positive
clinical studies: As recently announced, results from the Phase
3 CORAL Study in people with MDD met the trial objectives,
demonstrating a rapid and statistically significant reduction in
depressive symptoms in the zuranolone co-initiated with standard
antidepressant arm compared to the standard antidepressant
co-initiated with placebo arm at Day 3 and over the 2-week
treatment period, achieving the primary and key secondary
endpoints. In meeting its pre-defined objectives, the CORAL Study
supports the potential of zuranolone, when co-initiated with
standard of care, to accelerate the benefit of depression treatment
compared to treatment with antidepressant treatments (ADTs)
alone.
Planned New Drug Application (NDA) submission for
zuranolone: Sage and Biogen announced their plan to submit an
NDA to the U.S. Food and Drug Association (FDA) for zuranolone in
the second half of 2022, with rolling submission planned to begin
in early 2022.
- The initial submission package will seek approval of zuranolone
for the treatment of MDD. The decision to submit the application
follows discussions with the FDA, including a pre-NDA meeting.
- An associated NDA for PPD is expected to be filed pending
completion and results from the SKYLARK Study. The FDA granted Fast
Track Designation to zuranolone in PPD in early 2022.
Topline data from PARADIGM and LUMINARY Studies with
SAGE-718: SAGE-718 demonstrated improvements across multiple
domains of cognition in Phase 1 and Phase 2a studies of people with
cognitive impairment across several indications, including
Huntington’s disease (HD), Parkinson’s disease (PD) and Alzheimer’s
disease (AD). These findings support the Company’s belief in the
potential for SAGE-718 to be an important treatment for disorders
associated with cognitive dysfunction.
- The open-label PARADIGM Study evaluated SAGE-718 in people with
mild cognitive impairment due to PD. Data from the study showed
that SAGE-718 had a positive impact on multiple domains of
cognition, including executive function and learning and memory,
while leaving domains altering simple attention or reaction time
unaffected.
- The open-label LUMINARY Study evaluated SAGE-718 in people with
mild cognitive impairment and mild dementia due to AD. Data from
the study showed treatment with SAGE-718 resulted in consistent
improvement across multiple tests of executive performance, as well
as improvement on key tests of learning and memory. Notably, these
improvements were not driven by improvement in simple attention or
motor speed. Additionally, the study demonstrated improvement on
the Montreal Cognitive Assessment (MoCA) Test, a global measure of
cognition, that reached statistical significance at Day 28 when
compared to baseline in people treated with SAGE-718.
- SAGE-718 has been well-tolerated in studies to date.
Topline data from the KINETIC Study with SAGE-324:
- Sage and Biogen announced that the KINETIC Study, a Phase 2
multicenter, randomized, double-blind, placebo-controlled study of
SAGE-324 in Essential Tremor (ET), met its primary endpoint. In the
study, SAGE-324 demonstrated a statistically significant reduction
from baseline in The Essential Tremor Rating Assessment Scale
(TETRAS) Performance Subscale Item 4 upper limb tremor score at Day
29 in the total studied population compared to placebo.
- SAGE-324 also demonstrated a statistically significant
correlation between TETRAS upper limb tremor score and activities
of daily living at all measured time points.
- The most common TEAEs that occurred in ≥10% of patients in the
SAGE-324 treatment group and at a rate at least twice as high as
that of patients in the placebo group were: somnolence 68%;
dizziness 38%; balance disorder 15%; diplopia 12%; dysarthria 12%;
and gait disturbance 12%.
- SAGE-324 was dosed during the day at 60 mg, which Sage believes
is the highest end of the dose range.
Fourth Quarter 2021 Portfolio
Updates
Sage is advancing a portfolio of clinical programs featuring
internally-discovered novel chemical entities with the potential to
become differentiated products designed to improve brain health by
targeting the GABAA and NMDA receptor systems. Dysfunction in these
systems is thought to be at the core of numerous neurological and
neuropsychiatric disorders.
Depression Franchise
Sage’s depression franchise features zuranolone, Sage’s
next-generation positive allosteric modulator (PAM) of GABAA
receptors being evaluated in clinical development as a treatment
for various affective disorders, and ZULRESSO® (brexanolone) CIV
injection, approved by the FDA as the first treatment specifically
indicated for PPD. Zuranolone has received breakthrough therapy
designation from the FDA for the treatment of MDD.
Zuranolone is being evaluated as a potential rapid-acting,
once-daily, two-week treatment for MDD and PPD in the LANDSCAPE and
NEST clinical development programs, respectively. Sage and Biogen
plan to submit an NDA to the FDA for zuranolone in the second half
of 2022, with rolling submission planned to begin in early 2022.
The initial NDA submission will seek approval of zuranolone for the
treatment of MDD with an associated NDA filing for PPD anticipated
in the first half of 2023 pending completion and results from the
SKYLARK Study. The decision to submit the application follows
discussions with the FDA, including a pre-NDA meeting.
In February 2022, Sage and Biogen announced that the CORAL Study
in people with MDD met the trial objectives, demonstrating a rapid
and statistically significant reduction in depressive symptoms in
the zuranolone co-initiated with standard ADT arm compared to the
standard antidepressant co-initiated with placebo arm at Day 3 and
over the 2-week treatment period, achieving the primary and key
secondary endpoints. This significance was demonstrated at the
first measured time point, Day 3, with zuranolone 50 mg
co-initiated with an open-label standard of care ADT as assessed by
change from baseline in the 17-item Hamilton Rating Scale for
Depression (HAMD-17) compared to ADT co-initiated with placebo. The
CORAL Study also met its key secondary endpoint, with zuranolone
co-initiated with a standard of care ADT demonstrating a
statistically significant improvement in depressive symptoms
compared to ADT co-initiated with placebo, over the 2-week
treatment period. Zuranolone was generally well-tolerated, and no
new safety signals attributable to zuranolone were identified. In
meeting its pre-defined objectives, the CORAL Study supports the
potential of zuranolone, when co-initiated with standard of care,
to accelerate the benefit of depression treatment compared to
treatment with ADTs alone.
Additionally, Sage today announced that the FDA granted Fast
Track Designation to zuranolone for development in PPD. This
designation is granted to drug candidates that treat serious or
life-threatening conditions and demonstrate the potential to
address unmet medical needs.
The Company expects to achieve the following milestones across
its depression franchise in 2022, with plans to share additional
analyses throughout the year:
- Early 2022:
- Begin rolling NDA submission for zuranolone in MDD.
- Mid-2022:
- SKYLARK (PPD-301) Study: Report
topline data from the placebo-controlled Phase 3 study evaluating a
two-week course of zuranolone 50 mg in women with PPD, with
additional short-term follow-up.
- Late 2022:
- Complete rolling NDA submission for zuranolone in MDD (2H
2022).
- Announce topline data from the SUNBIRD Study, designed to
evaluate the safe-use administration of ZULRESSO for the treatment
of PPD in a patient’s home (late 2022).
Neuropsychiatry Franchise
Sage’s neuropsychiatry franchise features SAGE-718, the
Company’s first-in-class NMDA receptor PAM and lead
neuropsychiatric drug candidate, in development as a potential oral
therapy for cognitive disorders associated with NMDA receptor
dysfunction, potentially including HD, PD and AD. SAGE-718 received
Fast Track Designation from the FDA for development of SAGE-718 as
a potential treatment for HD.
SAGE-718 is currently being studied in the ongoing Phase 2
DIMENSION Study, a double-blind placebo-controlled study in people
with early to moderate HD cognitive impairment that is designed to
evaluate the efficacy of once-daily dosed SAGE-718 over three
months.
The Company expects to initiate the following studies in the
neuropsychiatry franchise in 2022:
- Mid-2022:
- SURVEYOR (CIH-202) Study: A
placebo-controlled Phase 2 study in people with HD cognitive
impairment and healthy volunteers, with the goal of generating
evidence linking efficacy signals on cognitive performance to
domains of real-world functioning.
- Phase 2 Study in PD (CNP-202): A
placebo-controlled Phase 2 study in people with mild cognitive
impairment due to PD.
- Late 2022:
- Phase 3 Study in HD (CIH-301): A
Phase 3 open-label extension study in people with HD cognitive
impairment.
- Phase 2 Study in AD (CNA-202): A
placebo-controlled Phase 2 study in people with mild cognitive
impairment and mild dementia due to AD.
Sage also plans to share additional analyses from studies
completed with SAGE-718 to date throughout 2022.
Additionally, the Company today announced its decision to
discontinue development of SAGE-904 following results from the
Phase 1 clinical program that showed it did not achieve the
company’s target product profile for further development.
Neurology Franchise
Sage’s neurology franchise features SAGE-324 and SAGE-689.
SAGE-324, a next-generation PAM of GABAA receptors and Sage’s lead
neurology program, is in development as a potential oral therapy
for neurological conditions, such as ET, epilepsy and PD. SAGE-689
is an intramuscular GABAA receptor PAM in development as a
potential therapy for disorders associated with acute GABA
hypofunction.
Sage and its collaborator, Biogen, are currently enrolling
people in the Phase 2b KINETIC 2 placebo-controlled study of
SAGE-324 in ET following positive results from the KINETIC Study
presented in 2021. The KINETIC 2 Study is a Phase 2b dose-ranging
study with the primary goal of defining the dose and frequency with
a good tolerability profile and a dosing schedule to maintain
plasma concentrations of SAGE-324 that translate into sustained
tremor symptom control in treating ET. KINETIC 2 will utilize
evening dosing.
SAGE-689 remains in Phase 1 development.
The Company expects to achieve the following milestones across
its neurology franchise in 2022:
- Mid-2022:
- Initiate a Phase 2 safety study with SAGE-324 in ET.
Sage also plans to share additional analyses from studies
completed with SAGE-324 to date throughout 2022.
Early Development
Sage is progressing its early development programs with
IND-enabling work underway for SAGE-319 and SAGE-421.
- SAGE-319: an oral, extrasynaptic GABAA receptor
preferring PAM that Sage plans to study for potential use in
disorders of social interaction.
- SAGE-421: an oral, NMDA receptor PAM that Sage plans to
study for potential use in neurodevelopmental disorders and
cognitive recovery and rehabilitation.
ANTICIPATED 2022
MILESTONES
- Zuranolone:
- Begin rolling NDA submission in MDD (early 2022)
- Report topline data from the SKYLARK Study in PPD
(mid-2022)
- Complete NDA submission in MDD (2H 2022)
- SAGE-718:
- Initiate SURVEYOR Study in HD cognitive impairment
(mid-2022)
- Initiate placebo-controlled Phase 2 study in people with mild
cognitive impairment due to PD (mid-2022)
- Initiate HD cognitive impairment open label extension study
(late 2022)
- Initiate placebo-controlled Phase 2 Study inpeople with mild
cognitive impairment and mild dementia due to AD (late 2022)
- SAGE-324:
- Initiate Phase 2 safety study in ET (mid-2022)
- ZULRESSO:
- Announce topline data from the SUNBIRD Study, designed to
evaluate the safe-use administration of ZULRESSO for the treatment
of PPD in a patient’s home (late 2022)
FINANCIAL RESULTS FOR THE FOURTH
QUARTER AND FULL YEAR 2021
- Cash Position: Cash, cash equivalents and marketable
securities as of December 31, 2021 were $1.7 billion compared to
$1.8 billion at September 30, 2021.
- Revenue: Net revenue from sales of ZULRESSO was $1.6
million in the fourth quarter of 2021 compared to $1.7 million in
the same period of 2020. For the year ended December 31, 2021, net
revenue from sales of ZULRESSO was $6.3 million compared to $6.7
million in the same period of 2020. Additionally, in the fourth
quarter of 2020, Sage recorded $1.1 billion of collaboration
revenue from Biogen that consisted of an upfront payment of $875
million plus $232.5 million in excess proceeds from the equity
investment under the stock purchase agreement.
- R&D Expenses: Research and development expenses were
$75.4 million, including $9.1 million of non-cash stock-based
compensation expense, in the fourth quarter of 2021 compared to
$81.7 million, including $10.1 million of non-cash stock-based
compensation expense, for the same period in 2020. For the year
ended December 31, 2021, R&D expenses were $283.2 million,
including $49.7 million of non-cash stock-based compensation
expense, compared to $292.7 million, including $42.4 million of
non-cash stock-based compensation expense, for the same period in
2020. For the year, the decrease in R&D expenses was primarily
due to the reimbursement from Biogen of $79.8 million pursuant to
the Sage/Biogen Collaboration and License Agreement, partially
offset by an increase in spending of $70.3 million. The increase in
spending was mainly attributable to increased spending on
zuranolone and Sage’s wholly owned pipeline including SAGE-718 and
other programs. For the year, non-cash stock-based compensation
expense increased because the Company incurred $9.8 million of
expense in 2021 due to the achievement of milestones for certain
outstanding performance restricted stock units and incurred no
expense for such grants in 2020.
- SG&A Expenses: Selling, general and administrative
expenses were $51.6 million, including $11.5 million of non-cash
stock-based compensation expense, in the fourth quarter of 2021
compared to $53.5 million, including $10.6 million of non-cash
stock-based compensation expense, for the same period in 2020. For
the year ended December 31, 2021, SG&A expenses were $183.5
million, including $54.9 million of non-cash stock-based
compensation expense, compared to $197.0 million, including $51.8
million of non-cash stock-based compensation expense, for the same
period in 2020. For the year, the decrease in SG&A expenses was
primarily due to the reimbursement from Biogen of $11.3 million
pursuant to the Sage/Biogen Collaboration and License Agreement,
along with the impact of the restructuring that the Company
announced during the second quarter of 2020. For the year, non-cash
stock-based compensation expense increased because the Company
incurred $6.7 million of expense in 2021 due to the achievement of
milestones for certain outstanding performance restricted stock
units and incurred no expense for such grants in 2020.
- Net Income (loss): Net loss was $124.7 million for the
fourth quarter of 2021 compared to net income of $974.9 million for
the same period in 2020. For the year ended December 31, 2021, net
loss was $457.9 million compared to net income of $606.1 million
for the same period in 2020. In both periods, the decrease was due
to the collaboration revenue from Biogen.
FINANCIAL GUIDANCE
- Sage anticipates cash, cash equivalents and marketable
securities of approximately $1.3 billion at the end of 2022.
- The Company does not anticipate receipt of any milestone
payments from collaborations in 2022.
- The Company believes its cash and cash equivalents, ongoing
collaboration funding, and potential revenue, will support its
operations into 2025.
Conference Call Information
Sage will host a conference call and webcast today, Thursday,
February 24, at 8:00 a.m. ET to discuss its fourth quarter and full
year 2021 financial results and recent corporate updates. The live
webcast can be accessed on the investor page of Sage's website at
investor.sagerx.com. A replay of the webcast will be available on
Sage's website approximately two hours after the completion of the
event and will be archived for up to 30 days.
About Sage Therapeutics
Sage Therapeutics is a biopharmaceutical company fearlessly
leading the way to create a world with better brain health. Our
mission is to pioneer solutions to deliver life-changing brain
health medicines, so every person can thrive. For more information,
please visit. www.sagerx.com.
Forward-Looking Statements
Various statements in this release concern Sage's future
expectations, plans and prospects, including without limitation our
statements regarding: plans for an NDA filing and associated
submission for zuranolone in MDD and PPD, and the potential timing
of such submissions; our belief in the adequacy of the data we plan
to include in the zuranolone NDA; the potential for FDA acceptance
of an NDA for zuranolone; our belief in the regulatory filing
pathways for zuranolone; the potential profile and benefit of
zuranolone in MDD and PPD; the potential for regulatory approval
and commencement of commercialization of zuranolone; other planned
next steps for the program; anticipated timelines for reporting
clinical trial results, commencement of trials, and initiation of
new activities; our plans for advancement of our pipeline; our
belief in the potential profile and benefit of our product
candidates; potential indications for our product candidates; the
potential for success of our programs, and the opportunity to help
patients in various indications; the mission and goals for our
business; and our expectations with respect to 2022 year-end cash,
no receipt of milestones from collaborations in 2022 and funding of
future operations. These statements constitute forward-looking
statements as that term is defined in the Private Securities
Litigation Reform Act of 1995. These forward-looking statements are
neither promises nor guarantees of future performance, and are
subject to a variety of risks and uncertainties, many of which are
beyond our control, which could cause actual results to differ
materially from those contemplated in these forward-looking
statements, including the risks that: we may experience delays or
unexpected hurdles in our efforts to submit an NDA for zuranolone
and we may not be able to submit the NDA on the timelines we expect
or at all; the FDA may find inadequacies and deficiencies in our
NDA for zuranolone, including in the data we submit, despite prior
discussions, and may decide not to accept the NDA for filing; even
if the FDA accepts the NDA for filing, the FDA may find that the
data included in the NDA are not sufficient for approval and may
not approve the NDA; the FDA may decide that the design, conduct or
results of our completed and ongoing clinical trials for
zuranolone, even if positive, are not sufficient for approval in
MDD or PPD and may require additional trials or data which may
significantly delay and put at risk our efforts to obtain approval
and may not be successful; the FDA may not meet expected review
timelines for our NDA; other decisions or actions of the FDA or
other regulatory agencies may affect our efforts with respect to
zuranolone and our plans, progress or results; we may experience
negative results in the ongoing SKYLARK Study in PPD that
negatively affect our ability to file an NDA for approval of
zuranolone or results of ongoing or future studies may impact our
ability to obtain approval of zuranolone or impair the potential
profile of zuranolone; success in earlier clinical trials of any of
our product candidates may not be repeated or observed in ongoing
or future studies, and ongoing and future clinical trials may not
meet their primary or key secondary endpoints which may
substantially impair development; unexpected concerns may arise
from additional data, analysis or results from any of our completed
studies; we may encounter adverse events at any stage of
development that negatively impact further development or that
require additional nonclinical and clinical work which may not
yield positive results; we may encounter delays in initiation,
conduct or completion of our ongoing and planned clinical trials,
including as a result of slower than expected site initiation or
enrollment, the need or decision to expand the trials or other
changes, that may impact our ability to meet our expected timelines
and increase our costs; decisions or actions of the FDA or other
regulatory agencies may affect the initiation, timing, design,
size, progress and cost of clinical trials and our ability to
proceed with further development or may impair the potential for
successful development; the anticipated benefits of our ongoing
collaborations, including the achievement of events tied to
milestone payments or the successful development or
commercialization of products and generation of revenue, may never
be achieved; the need to align with our collaborators may hamper or
delay our development and commercialization efforts or increase our
costs; our business may be adversely affected and our costs may
increase if any of our key collaborators fails to perform its
obligations or terminates our collaboration; the internal and
external costs required for our ongoing and planned activities, and
the resulting impact on expense and use of cash, may be higher than
expected which may cause us to use cash more quickly than we expect
or change or curtail some of our plans or both; we may never be
able to generate meaningful revenues from sales of ZULRESSO or to
generate revenues at levels we expect or at levels necessary to
justify our investment; we may not be successful in our efforts to
gain regulatory approval of products beyond ZULRESSO and, even if
successfully developed and approved, we may not achieve revenues
from such products at the levels we expect; our expectations as to
year-end cash and sufficiency of cash to fund future operations may
prove not to be correct for these and other reasons such as changes
in plans or actual events being different than our assumptions; we
may be opportunistic in our future financing plans even if
available cash is sufficient; additional funding may not be
available on acceptable terms when we need it; the number of
patients with the diseases or disorders for which our products are
developed, the unmet need for additional treatment options and the
potential market for our current or future products may be
significantly smaller than we expect; and we may encounter
technical and other unexpected hurdles in the development and
manufacture of our product candidates or the commercialization of
our marketed product which may delay our timing or change our
plans, increase our costs or otherwise negatively impact our
business; as well as those risks more fully discussed in the
section entitled "Risk Factors" in our Annual Report on Form 10-K,
as well as discussions of potential risks, uncertainties, and other
important factors in our subsequent filings with the Securities and
Exchange Commission. In addition, any forward-looking statements
represent our views only as of today, and should not be relied upon
as representing our views as of any subsequent date. We explicitly
disclaim any obligation to update any forward-looking
statements.
Financial Tables
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Statements of Operations (in thousands, except
share and per share data) (unaudited)
Three Months
Ended December 31, Year Ended December 31,
2021
2020
2021
2020
Product revenue, net
$
1,642
$
1,686
$
6,308
$
6,700
Collaboration revenue
-
1,107,500
-
1,107,500
Total revenue
1,642
1,109,186
6,308
1,114,200
Operating costs and expenses:
Cost of goods sold
87
136
553
565
Research and development
75,443
81,706
283,166
292,714
Selling, general and administrative
51,599
53,498
183,498
196,952
Restructuring
-
(130
)
-
27,743
Total operating costs and expenses
127,129
135,210
467,217
517,974
Income (loss) from operations
(125,487
)
973,976
(460,909
)
596,226
Interest income, net
751
834
2,883
9,597
Other income, net
24
85
134
250
Net income (loss)
$
(124,712
)
$
974,895
$
(457,892
)
$
606,073
Net income (loss) per share - basic
$
(2.12
)
$
18.71
$
(7.80
)
$
11.66
Net income (loss) per share - diluted
$
(2.12
)
$
18.19
$
(7.80
)
$
11.43
Weighted average shares outstanding - basic
58,897,195
52,115,022
58,670,230
51,983,188
Weighted average shares outstanding - diluted
58,897,195
53,594,637
58,670,230
53,003,115
Sage Therapeutics, Inc. and Subsidiaries Condensed
Consolidated Balance Sheets (in thousands) (unaudited)
December 31, 2021
December 31, 2020
Cash, cash equivalents and marketable securities
$
1,742,296
$
2,099,549
Total assets
$
1,825,288
$
2,159,246
Total liabilities
$
96,257
$
86,912
Total stockholders' equity
$
1,729,031
$
2,072,334
ZULRESSO (brexanolone) SELECT IMPORTANT SAFETY
INFORMATION
This does not include all the information needed to use ZULRESSO
safely and effectively. See full prescribing information for
ZULRESSO.
WARNING: EXCESSIVE SEDATION AND SUDDEN LOSS OF
CONSCIOUSNESS See full prescribing information for complete
boxed warning Patients are at risk of excessive sedation or
sudden loss of consciousness during administration of
ZULRESSO.
Because of the risk of serious harm, patients must be
monitored for excessive sedation and sudden loss of consciousness
and have continuous pulse oximetry monitoring. Patients must be
accompanied during interactions with their child(ren).
ZULRESSO is available only through a restricted program
called the ZULRESSO REMS.
WARNINGS AND PRECAUTIONS Suicidal Thoughts and
Behaviors: Consider changing the therapeutic regimen, including
discontinuing ZULRESSO, in patients whose PPD becomes worse or who
experience emergent suicidal thoughts and behavior.
ADVERSE REACTIONS: Most common adverse reactions
(incidence ≥5% and at least twice the rate of placebo) were
sedation/somnolence, dry mouth, loss of consciousness, and
flushing/hot flush.
USE IN SPECIFIC POPULATIONS • Pregnancy: ZULRESSO
may cause fetal harm. Healthcare providers are encouraged to
register patients by calling the National Pregnancy Registry for
Antidepressants at 1-844-405-6185 or visiting online at
https://womensmentalhealth.org/clinical-and-researchprograms/pregnancyregistry/antidepressants/
• Renal Impairment: Avoid use of ZULRESSO in patients with
end stage renal disease (ESRD)
Controlled Substance: ZULRESSO contains brexanolone, a
Schedule IV controlled substance under the Controlled Substances
Act.
To report SUSPECTED ADVERSE REACTIONS, contact Sage
Therapeutics, Inc. at 1-844-4-SAGERX (1-844-472-4379) or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch. Please see accompanying
full Prescribing Information including Boxed Warning.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220223006370/en/
Investor Contact Helen Rubinstein 315-382-3979
helen.rubinstein@sagerx.com Media Contact Maureen L. Suda
617-949-4289 maureen.suda@sagerx.com
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