The study of 324 complex plastic surgery
procedures demonstrated many benefits of using DSUVIA for
analgesia, including avoiding the need for general
anesthesia
HAYWARD,
Calif., Oct. 31, 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 an abstract, entitled,
"Experience in Complex Outpatient Plastic Surgery Procedures Using
Sufentanil Sublingual Tablets" was presented on Friday, October 28th by Jeffrey DeWeese, M.D., FACS, at Plastic Surgery
The Meeting 2022, held October 27-30,
in Boston, MA. The study,
conducted in 324 patients undergoing complex plastic surgery
procedures, found many positive benefits of using sufentanil
sublingual tablets (SST), 30 mcg (brand name DSUVIA®), including
the ability to perform complex, extensive cosmetic procedures
without general anesthesia, allowing a rapid discharge time.
This "awake" surgery analysis was a prospective, single-group
cohort that were 95% female and ranged in age from 15 to 81
years. The study was conducted at Precision M.D. Cosmetic
Surgery Center in Elk Grove,
CA. Procedures included liposuction, breast augmentation,
breast reduction, brachioplasty, facelift, rhinoplasty, and
blepharoplasty, and most significantly, abdominoplasty, which is
usually only performed under general anesthesia. Many combination
procedures were also undertaken. Patients were administered 1 to 3
mg of oral lorazepam for anxiolysis/sedation and an IV was placed
for antibiotic and preemptive antiemetic treatment only. A
sufentanil sublingual tablet (SST) 30 mcg (DSUVIA®) was
administered sublingually, followed by injection of local and/or
tumescent anesthesia. Surgery was initiated 20 to 30 minutes after
local anesthetic administration, allowing time for the sufentanil
plasma concentrations to approach peak levels. Additional SST doses
were then given as needed, with a minimum of 60 minutes between
dosing. Median tablet use per procedure was 2 tablets of SST 30
mcg. Additional sedatives or antiemetic drugs were rarely required.
Breakthrough discomfort or anxiety for patients was managed by
inhaled 50% nitrous oxide, but this was rarely necessary. No
unstable vital signs were reported and naloxone was not required by
any patient for respiratory depression. Complications included
shortening or modifying the procedure due to discomfort on rare
occasions. Patient recovery time in the center averaged 19
minutes.
The study found that implementing the use of SST in this
surgical center resulted in the ability to successfully perform
complex, longer duration procedures without general anesthesia or
intravenous (IV) opioids. The investigator also found that the
absence of cognitive impairment after extended awake surgery
allowed for an easier and more rapid discharge than usual compared
to their typical experience when the same procedures are performed
under general anesthesia.
"The lack of cognitive impairment, even after extended awake
surgery, allowed for an easier discharge of patients compared to my
experience when the same procedures are conducted under general
anesthesia," stated Dr. DeWeese. "Implementing SST into
our protocols in our outpatient surgical center has resulted in the
ability to perform complex, lengthy procedures without general
anesthesia. Patients often prefer to avoid the cost and adverse
events associated with general anesthesia and SST provides
significant analgesia to allow a comfortable experience for these
patients."
Dr. Pamela Palmer, co-founder and Chief Medical Officer of
AcelRx, stated, "While this awake approach to performing plastic
surgery procedures using SST has been reported recently by other
investigators, this cohort of over 300 plastic surgery cases was
remarkable for the complexity of the cases, many of which would
have normally been performed under general anesthesia. We
were pleased to learn that not only were rescue analgesics rarely
required for patient breakthrough pain, but also that the surgeons
were able to comfortably perform complex procedures and safely
discharge the patient so quickly after relatively prolonged
surgical cases. DSUVIA allows an option for patients not wanting to
undergo general anesthesia for both short and lengthy plastic
surgery procedures."
About Plastic Surgery The Meeting
Plastic Surgery The
Meeting brings together plastic surgeons from countries around the
globe. It is the premier educational and networking event of the
year, for both domestic and international plastic surgeons. It is
considered to be the annual meeting of The American Society of
Plastic Surgeons (ASPS), the largest plastic surgery specialty
organization in the world, representing 94% of all board-certified
plastic surgeons in the U.S., and more than 11,000 plastic surgeons
worldwide. ASPS is considered a global institution and leading
authority on cosmetic and reconstructive plastic surgery. The
meeting also convenes members of The Plastic Surgery Foundation
(PSF), the American Society of Maxillofacial Surgeons (ASMS), and
the World Society for Simulation Surgery.
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.