Study results show higher rates of successful
procedure completion and higher patient and clinician satisfaction
scores compared to topical local anesthesia alone
HAYWARD,
Calif., March 31, 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 a study evaluating the use of a
sufentanil sublingual tablet (SST) 30 mcg for management of pain of
radiofrequency ("RF") microneedling of the face or abdomen. The
article entitled "Novel Sublingual Analgesic Improves Patient
Tolerance of Face and Body Radiofrequency Microneedling: A Split
Face/Abdomen Study" was lead authored by Dr. Talon Maningas and published in the journal
American Journal of Cosmetic Surgery. Dr. Maningas is a
nationally recognized cosmetic surgeon and is certified by the
American Board of Cosmetic Surgery, the American Board of Facial
Cosmetic Surgery, and the American Osteopathic Board of
Otolaryngology.
The study was a prospective, open-label, controlled study at two
clinical sites comparing topical local anesthetic alone (control
side) to topical local anesthetic plus SST 30 mcg administered 30
minutes prior to initiation of the RF microneedling to the face or
abdomen (SST-treated side). The study was a one-way crossover
"split" face or abdomen study, meaning one treatment was performed
on one side of the face or abdomen and the other treatment on the
opposite side, allowing patients to act as their own control.
Outcome measures included percent of patients successfully
completing the full treatment with prespecified needle depth and RF
energy settings, Richmond Agitation-Sedation Scale (RASS) scores
which objectively assesses patients' level of agitation or
sedation, patient and clinician satisfaction scores, as well as
vital signs and adverse events.
A total of 51 patients were evaluated across both sites with 26
patients undergoing RF microneedling of the face and 25 patients
undergoing the procedure on the abdomen. The results from the study
are as follows:
- Whereas only 45% of patients successfully completed the
procedure on their control side, 96% of patients successfully
completed the procedure on their SST-treated side (p <
0.001).
- Patients were less restless or agitated during the SST-treated
side procedure (6% restless or agitated) compared to during the
control-side procedure (51% restless or agitated) as measured using
the RASS scoring system; p < 0.001).
- Patient-reported satisfaction with pain control improved
significantly with the SST-treatment side procedure as compared to
the control-treated side procedure (p < 0.001).
- Clinician (provider) satisfaction with the comfort level of the
patient also improved significantly for the SST-treated side
compared to the control side (p < 0.001).
- Vital signs remained stable with SST treatment compared to the
control side and no patient required supplemental oxygen. Nausea
and vomiting (each 5.9%) and dizziness (2%) occurred only after the
procedure was completed on both sides and symptoms resolved with
treatment in the recovery room.
Study limitations include the open-label design and, due to the
half-life of SST, the study was performed as a one-way crossover
from topical local anesthetic only to topical local anesthetic plus
SST.
"RF microneedling is a minimally invasive cosmetic procedure,
but at the most effective clinical settings it can be painful for
many patients, making tolerance difficult," said Dr. Maningas.
"Prior to adopting DSUVIA® in our practice we would either have to
reduce the energy settings, yielding less effective results, or
perform more invasive anesthesia measures. I now use DSUVIA as a
standard of care for my RF microneedling procedures which allows
for more patient comfort, a better cosmetic outcome and saves time
in our busy practice. While the study showed a low rate of nausea
and vomiting, we now pre-treat with an oral antiemetic and rarely
see these side effects."
"We have heard repeated physician feedback over the past few
years that DSUVIA is significantly improving patient comfort during
painful cosmetic procedures, but this is the first prospective,
controlled study demonstrating statistically significant
superiority over a traditional analgesic regimen," stated
Dr. Pamela Palmer, AcelRx Chief Medical Officer and
co-founder. "If patients are suffering from pain so severe that it
can limit the effectiveness of a procedure, this has to be
acknowledged and remedied. DSUVIA provides an effective alternative
approach to managing acute pain in these cosmetic procedural suites
that can avoid reliance on more complicated methods, such as the
use of nerve blocks or IV sedation."
AcelRx did not provided funding for the conduct of the study and
no authors were consultants for AcelRx throughout the study
conduct. Since acceptance of manuscript for publication, Dr.
Maningas has received funding for consulting work from AcelRx.
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™(nafamostat mesylate), 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.
This release is intended for investors only.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-announces-publication-of-results-from-a-clinical-study-assessing-use-of-sufentanil-sublingual-tablet-for-painful-radiofrequency-microneedling-procedures-301515290.html
SOURCE AcelRx Pharmaceuticals, Inc.