HAYWARD, Calif., May 13, 2021 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in a medically
supervised setting, today announced a poster presentation at the
46th Annual Regional Anesthesiology and Acute Pain
Medicine Meeting reviewing the results of a study on the
intraoperative administration of DSUVIA (sufentanil sublingual
tablet; SST) 30 mcg for the management of acute pain in an
ambulatory surgery center. The primary objective of this study was
to determine if SST 30 mcg given prior to emergence from anesthesia
was efficacious in reducing initial post anesthesia care unit
(PACU) pain scores compared to a control group. Secondary outcomes
included opioid use and percentage of patients opioid free in PACU,
and time until ready to discharge.
The study was a prospective, randomized, controlled trial
conducted at an ambulatory surgery center with patients aged 18-80
undergoing orthopedic surgery under general anesthesia. A
total of 50 patients were included in the final analysis. There
were no significant differences in baseline characteristics or
duration of surgery between the two groups. The pain score on
arrival to PACU was not significantly different between either
group. However, patients in the SST group required 50% less opioids
in the PACU (p=0.018), with significantly more of them opioid-free
(36% vs 8%; p=0.037). Furthermore, SST-treated patients had
improved overall benefit of analgesia scores (OBAS) compared to the
control group (p=0.006). OBAS is a validated 7-item tool that
assesses pain intensity, adverse effects and patients' satisfaction
with analgesia.
The authors concluded that while SST 30 mcg administered
intraoperatively did not affect patients' pain scores on arrival to
PACU, patients that received SST did show improvement in PACU
opioid requirements and OBAS scores, with more of them opioid-free
in the PACU. The authors stated that the most compelling result of
this study was the significant difference in OBAS and percent of
opioid-free patients in the SST group, reflecting greater patient
satisfaction with SST, which is more meaningful than a single pain
score assessed at any given point in time. Objectively, the higher
patient satisfaction was supported by the significantly lower
rescue opioid requirement observed in the SST group. Limitations of
the study include that the SST was not compared to an active
comparator, in that it did not allow for preemptive opioid
analgesia in the control group. Also, as the data collection ended
at discharge, the authors were unable to assess any additional
analgesic benefit of SST beyond the immediate postoperative
period.
Details of the presentation and the link to the poster is as
follows:
https://epostersonline.com/ASRASPRING21/node/694?view=true
Title: Intraoperative sublingual sufentanil for acute pain in
the ambulatory surgery center
Date & Time: Thursday, May 13, 2021; 10:30am-12:00pm ET
Location: Disney's Yacht & Beach Club, Lake Buena Vista, FL
Presenter: Justin A. Mottaghi,
MD
One of the investigators of the study is a paid consultant for
AcelRx but was not compensated for this study.
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. The
European Commission approved DZUVEO for marketing in Europe and the Company is currently in
discussions with potential European marketing partners.
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 one product candidate, Zalviso®
(sufentanil sublingual tablet system, SST system, 15 mcg), an
investigational product in the U.S., is being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings. DZUVEO and Zalviso are both approved products in
Europe.
For additional information about AcelRx, please visit
www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.