HAYWARD,
Calif., April 25, 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 a summary of results from a
podium presentation on DSUVIA® (sufentanil sublingual tablet (SST),
30 mcg) presented at the annual meeting of The Aesthetic Society®,
"The Aesthetic Meeting 2022", held from April 20 -24 at the San
Diego Convention Center.
The podium presentation was entitled "Improved Patient
Experience and Opioid Minimalization in Outpatient Plastic Surgery
Procedures Using a Sufentanil Sublingual Tablet" and was presented
April 24th by Hisham Seify, MD, PhD, FACS, a board-certified
plastic surgeon, past-president of the Orange County Society of
Plastic Surgeons, and Associate Clinical Professor at the David
Geffen UCLA School of Medicine. Some of the data presented at the
meeting were from an investigator-initiated trial supported by
AcelRx. The data were collected from a total of 124 patients during
both "awake" cosmetic procedures as well as patients undergoing
more lengthy cosmetic procedures under general anesthesia. All 92
SST-treated patients received a single SST administered either 30
minutes prior to shorter-duration procedures, or 45 minutes prior
to extubation for longer-duration procedures. The 32 "control"
patients all received general anesthesia with standard intravenous
(IV) opioids.
For patients undergoing general anesthesia, the control group
required significantly more IV morphine milligram equivalents (MME)
during recovery than SST-treated patients. The average dose of
opioids administered in the post-anesthesia care unit (PACU) to
control patients was more than five-fold higher than SST-treated
patients, with controls receiving 3.60 ± 2.65 MME as contrasted
with SST-treated patients that were administered an average of 0.64
± 2.31 MME (p <.001). In the awake surgery patients, no
SST-treated patients required opioids or other analgesics in the
PACU for pain. The mean recovery time was under an hour for the
general anesthesia SST-treated patients and only 15 minutes for the
awake cosmetic SST-treated patients.
Adverse events requiring medical intervention following general
anesthesia were minimal in SST-treated patients with 1.6% requiring
additional antiemetics in the PACU compared to 9.4% of control
patients. In awake cosmetic patients, 3.2% of SST-treated patient
required an antiemetic in the PACU for treatment of nausea.
"My extensive experience with operating on patients treated with
DSUVIA, including the patients in this study, has reinforced my
earlier observations that DSUVIA is a unique sublingual
alternative to IV opioids that can clearly enhance the standard of
care in perioperative analgesia," states Dr. Seify. "Administering
a sublingual opioid to surgical patients that is well-tolerated,
avoids the traditional peaks and troughs of IV administration, and
substantially reduces the use of postoperative opioids, thereby
facilitating a timely discharge, represents an exciting progression
in the management of perioperative pain in the surgical setting,"
continues Dr. Seify.
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 a 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, including the
following: 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™ (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.
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SOURCE AcelRx Pharmaceuticals, Inc.