HAYWARD, Calif., Feb. 1, 2022 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for use in medically supervised settings,
today announced the publication of real-world data in patients
undergoing awake plastic surgery showing a rapid recovery time and
minimal side effects with the use of sufentanil sublingual tablet
(SST) for pain management.
The article entitled "Awake Plastic Surgery Procedures: The Use
of a Sufentanil Sublingual Tablet to Improve Patient Experience"
was authored by Dr. Hisham Seify
from Newport Plastic Surgery in Newport
Beach, California and published in Aesthetic Surgery
Journal Open Forum with an accompanying video as supplemental
material. The study was a prospective single cohort study conducted
at his center. Following oral antiemetic prophylaxis with
ondansetron, SST was administered approximately 30 minutes prior to
the procedure followed by local anesthetic infiltration depending
on the procedure. Outcome measures included the number of patients
requiring medications during the procedure or in the
post-anesthesia care unit (PACU), recovery time and adverse
events.
A total of 31 patients were enrolled, including 28 females
and 3 males ranging in age from 23-71 years, with an average age of
47 years. The most common procedures were liposuction (71%),
facelift (10%), and blepharoplasty (6%) and the mean procedural
duration was 81 minutes.
Key findings from the study included:
- All 31 patients completed the plastic surgery procedures
successfully without disruption from inadequate analgesia
- No additional analgesics (aside from SST and local anesthetic
infiltration) were provided intraoperatively or in the PACU (post
anesthesia care unit) for pain
- The average recovery time was 15 ± 4 minutes
- Patient vital signs were stable during the procedures and in
recovery, and there was no oxygen desaturation observed and no
supplemental oxygen required
- Three patients experienced nausea, only one of which required
treatment with oral ondansetron 4 mg in the PACU, and one patient
experienced dizziness
Study limitations include that there was a small sample size
evaluated, and there was no control group of patients. Data
collection is ongoing to examine outcomes in a larger number of
patients.
"Awake plastic surgery has advantages including patient
preference, affordability, and easier recovery compared to when
performed under deeper sedation. Commonly used oral analgesics are
often not adequate to provide sufficient analgesia for these
procedures. The results from this study illustrate how
administering a single dose of SST 30 minutes prior to awake
plastic surgery procedures can provide effective pain management
with a low rate of adverse events, especially no excessive sedation
or impairment of cognitive function in the PACU that would delay
discharge," said Dr. Hisham Seify.
"The patients' pain was well managed, and they were able to leave
the surgery center on average approximately 15 minutes after the
procedure. The patients were very pleased with their rapid recovery
time. This sublingual analgesic with a rapid onset of action has a
side-effect profile consistent with the criteria for minimal
sedation and is an important addition to my protocol for awake
plastic surgery procedures."
"Published real-world studies continue to demonstrate that
DSUVIA® is well tolerated and provides benefits to patients and
physicians across various perioperative settings," stated
Dr. Pamela Palmer, AcelRx Chief Medical Officer and
co-founder. "We look forward to seeing the results of the multiple
ongoing studies currently being performed that will provide more
real-world evidence of how DSUVIA is being utilized."
Dr. Seify is a paid consultant for AcelRx but was not
compensated for this study. AcelRx did not provide funding for the
conduct of the study but did fund medical writing support.
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; 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 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.