HAYWARD, Calif., Aug. 30, 2021 /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 the results of a study
evaluating sufentanil sublingual tablet 30 mcg (SST) for outpatient
plastic surgery that was presented during the Miami Cosmetic
Surgery (MCS) conference on Friday, August
27th at the Miami
Beach Convention Center in Miami
Beach, Florida.
The presentation by Azza Halim,
MD and Hisham Seify, MD, PhD, FACS
shared data on the administration of SST and its effect on reducing
post-operative recovery time and opioid use in the outpatient
plastic surgery setting in patients undergoing "awake" procedures
not under general anesthesia. The authors were presented with a MCS
2021 Maverick Program Award in which the recipients' "progressive,
innovative ideas have been recognized for the lasting impact they
will have on medical aesthetics."
The presentation detailed the protocol for dosing SST 30 minutes
prior to starting awake plastic surgery procedures. A total of 25
cases were analyzed, with an average patient age of 46.1 ± 2.4
years and 92% were female. The cases were mainly liposuction (68%),
followed by facelifts (12%), blepharoplasties (8%) and 3 other
cases with an average duration of 1 hr 24 min ± 10 min. Following
the preoperative SST dose and local anesthetic infiltration, no
other analgesics were required throughout the intraoperative and
recovery period with recovery time averaging 15 ± 5 min. There were
2 cases of nausea, only one of which required treatment with
ondansetron 4 mg oral disintegrating tablet, and no cases of
vomiting or any other adverse events. The presenters emphasized the
reduction in opioid use and recovery time that the addition of SST
has had on their practice.
Dr. Halim is a board-certified anesthesiologist who specializes
in cosmetic surgeries. Dr. Seify is a board-certified plastic
surgeon and the past-president of the Orange County Society of
Plastic Surgeons. "Dosing a single preoperative SST allowed
us to avoid any additional analgesic administration during both the
intraoperative and recovery periods, which resulted in these
patients being ready for discharge almost immediately following
these fairly lengthy procedures," states Dr. Seify. "The low rate
of side effects also avoided prolonged delays during recovery,"
states. Dr. Seify.
Dr. Seify is a paid consultant for AcelRx but was not
compensated for this study. Dr. Halim is not a paid consultant for
AcelRx. Limitations of this study are that it was a single-arm,
open-label case series.
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 it will be commercialized by
AcelRx's European partner, Aguettant.
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, and
two pre-filled, ready-to-use syringes of ephedrine and
phenylephrine licensed for the U.S. from Aguettant. 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.