HAYWARD, Calif., June 1, 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 important findings from a
podium presentation on DSUVIA (sufentanil sublingual tablet 30 mcg)
during the Best Papers of the Regional Societies session at
the California Society of Plastic Surgeons 71st Annual
Meeting in Monterey CA.
The presentation entitled "The Use of Sublingual Sufentanil for
Peri-operative Pain Management in an Outpatient and Clinic Setting"
was presented on May 31, 2021 by
Hisham Seify, MD, PhD, FACS and
reported on data collected from a total of 76 patients during both
short and long-duration general anesthesia plastic surgery cases as
well as "awake" cosmetic procedures performed at the Newport
Plastic and Reconstructive Surgery's center. Procedures were
performed utilizing a single DSUVIA tablet in combination with
general anesthesia. Patients undergoing short (< 1 hour)
procedures required no opioids in the postanesthesia care unit
(PACU) and had an average recovery time of 33 minutes with no
adverse events reported. Following long-duration procedures, which
often included multiple cosmetic procedures combined (averaging
approximately 3 hours), 89% of the patients were opioid-free in the
PACU, recovery time averaged 1 hour and the only adverse event
was one patient that had nausea. Dr. Seify also presented his
protocol for using DSUVIA during "awake" surgery cases and reported
that to date they had seen no adverse events or vital sign
instability in these patients. The data presented at the meeting
are from an investigator-initiated trial supported by AcelRx. Dr.
Seify is a paid consultant for AcelRx.
"The results from these 76 patients demonstrated that the use of
DSUVIA allowed for enduring pain control into the postoperative
period regardless of whether the surgical procedure was short or
extensive, with little need for rescue opioids during recovery,"
states Dr. Seify. "The almost complete lack of adverse events
experienced by these patients, including no sedating effects of
DSUVIA, allowed us to discharge them in an hour or less, even when
they underwent a 3-hour procedure," 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. The
European Commission approved DZUVEO for marketing in Europe and the Company is currently in
discussions with potential European marketing partners.
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 one product candidate, Zalviso®
(sufentanil sublingual tablet system, SST system, 15 mcg), an
investigational product in the U.S., is being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings. 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.