Brigham and
Women's Hospital study found that SST-treated patients had
significantly lower pain scores in the post-operative care unit
(PACU) compared with patients in the two intravenous opioid control
groups following major spine surgery
HAYWARD,
Calif., Oct. 26, 2022 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in medically
supervised settings, today announced that the results of a
190-patient, investigator-initiated trial conducted at Brigham and Women's Hospital in Boston, MA, entitled, "The Impact of
Sublingual Sufentanil on Postoperative Pain Control in Patients
Undergoing Spine Surgery" (abstract # A4262), was presented at
the ANESTHESIOLOGY® 2022 annual meeting, held October 21-25, 2022 in New Orleans, LA. The study found that patients
who underwent major spine surgery had significantly lower reported
postoperative pain scores when treated with sufentanil sublingual
tablet (SST), 30 mcg (DSUVIA®) versus intravenous (IV) opioids.
The senior author of the study was Richard Urman M.D., Associate Professor and
Founding Co-Director, Center for Perioperative Research, Department
of Anesthesiology at Brigham and
Women's Hospital. The study was an Institutional Review Board
(IRB)-approved, prospective trial comparing an SST-treated cohort
(n=30) with a two-arm (n=80 each) historical matched control. Study
inclusion criteria consisted of patients 18 years or older
undergoing spine surgery (up to 3 levels) and a planned inpatient
stay. Both the prospective arm and two retrospective control
arms received standard general anesthetic, except the prospective
SST arm received intraoperative sufentanil IV infusion and an
initial dose of SST immediately following extubation. SST was
re-dosed as needed, no more than hourly, in the postoperative care
unit (PACU) for numeric rating scale (NRS) pain scores of greater
than 3 out of 10. Hydromorphone IV bolus was used for breakthrough
pain not controlled by SST. Control Arm 1 received intraoperative
remifentanil IV infusion and Control Arm 2 received intraoperative
sufentanil IV infusion and both received hydromorphone IV bolus as
the primary analgesic in the PACU as needed for NRS scores of
greater than 3. A multi-variable linear regression adjustment and
an inverse probability of treatment weighting was used to measure
the effectiveness of SST in decreasing postoperative pain scores in
the PACU as the primary outcome.
A total of 190 patients were analyzed and demographics were
relatively similar among the groups. As a result of the linear
regression model, adjusting for age, sex, BMI, ASA classification,
surgical invasiveness, and medication history, the authors found
that patients in the study group who received SST experienced
statistically significantly lower pain scores in the PACU compared
with the two IV opioid control groups (p<0.001). The SST group
had a mean ± standard deviation NRS score of 3.2 ± 2.4, whereas the
remifentanil/hydromorphone group averaged an NRS score of 5.7 ± 2.2
and the sufentanil/hydromorphone group averaged an NRS score of 5.0
± 2.4.
The authors concluded that use of SST appears to be an effective
alternative analgesic therapy in spine surgery patients who
experience moderate to severe postoperative pain resulting in
improved pain scores in the PACU, and, that further analysis of the
data will examine the impact on postoperative opioid consumption
and hospital length of stay.
"The dramatic difference in PACU pain scores reported after
major spine surgery is impressive," said Dr. Pamela Palmer, co-founder and Chief Medical
Officer of AcelRx, who provided funding for the study.
"Remifentanil and sufentanil are often used as infusions
intraoperatively during spine surgery due to their high therapeutic
index and rapid clearance, but they are too short-acting to
administer as IV boluses in the PACU. Therefore longer-acting IV
opioids such as hydromorphone are often used in recovery, but they
suffer from a lower therapeutic index, slower blood/brain
equilibration and active metabolites, which are associated with
delayed adverse events. This study demonstrates the utility of
administering sufentanil sublingually to provide an optimal opioid
analgesic via a route that allows a significant duration of action,
providing significantly better analgesia during the recovery
period."
E-Abstracts were presented virtually and made available to
registrants throughout the entire meeting from Saturday,
October 22 (7:00 a.m. US Central Time)
through Tuesday, October 25, 2022 (3:00
p.m. U.S. Central Time). The abstracts remain available
and open to meeting attendees for three months after the
meeting.
About the ANESTHESIOLOGY 2022 Annual Meeting
The ANESTHESIOLOGY Annual Meeting is the annual meeting for the
American Society of Anesthesiologists®. Founded in 1905, the
American Society of Anesthesiologists is an educational, research
and scientific association of physicians organized to
raise the standards of the medical practice of anesthesiology
and to improve patient care. As of 2021, the organization included
more than 55,000 national and international members.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known as DZUVEO® in Europe, is indicated for use in adults in
certified medically supervised healthcare settings, such as
hospitals, surgical centers, and emergency departments, for the
management of acute pain severe enough to require an opioid
analgesic and for which alternative treatments are inadequate.
DSUVIA was designed to provide rapid analgesia via a non-invasive
route and to eliminate dosing errors associated with intravenous
(IV) administration. DSUVIA is a single-strength solid dosage form
administered sublingually via a single-dose applicator (SDA) by
healthcare professionals. Sufentanil is an opioid analgesic
previously only marketed for IV and epidural anesthesia and
analgesia. The sufentanil pharmacokinetic profile, when delivered
sublingually, avoids the high peak plasma levels and short duration
of action observed with IV administration. DZUVEO has been approved
by the European Medicines Agency and AcelRx's European
commercialization partner, Aguettant, will market the drug in
Europe.
This release is intended for investors only. For more
information, including important safety information and black box
warning for DSUVIA, please visit www.DSUVIA.com.
About AcelRx Pharmaceuticals, Inc.
AcelRx
Pharmaceuticals, Inc. is a specialty pharmaceutical company focused
on the development and commercialization of innovative therapies
for use in medically supervised settings. AcelRx's proprietary,
non-invasive sublingual formulation technology delivers sufentanil
with consistent pharmacokinetic profiles. The Company has one
approved product in the U.S., DSUVIA® (sufentanil sublingual
tablet, 30 mcg), known as DZUVEO® in Europe, indicated for the management of acute
pain severe enough to require an opioid analgesic for adult
patients in certified medically supervised healthcare settings, and
several product candidates. The product candidates include:
Zalviso® (sufentanil sublingual tablet system, SST system, 15 mcg),
an investigational product in the U.S. being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings; two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant; Niyad™, a
regional anticoagulant for the extracorporeal circuit; and LTX-608,
for the potential treatment of COVID-19, disseminated intravascular
coagulation, acute respiratory distress syndrome and acute
pancreatitis. DZUVEO is an approved product in Europe.
This release is intended for investors only. For additional
information about AcelRx, please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.