REDWOOD CITY, Calif.,
Feb. 17, 2021 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for use in healthcare
institutions, today announced an agreement with Newport Plastic and
Reconstructive Surgery Associates for an investigator-initiated
study analyzing data from the historical use of DSUVIA (sufentanil
sublingual tablet 30 mcg) for various same-day plastic surgery
procedures.
The principal investigator, Dr. Hisham
Seify, is a board-certified plastic surgeon and the
past-president of the Orange County Society of Plastic Surgeons.
The study will focus on the efficacy and safety of DSUVIA for use
in general anesthesia plastic surgery cases, and "awake" cosmetic
procedures performed at Newport Plastic and Reconstructive
Surgery's center. Data from a total of 70 patients will be
evaluated for endpoints which will include the utilization of
DSUVIA (number of doses, timing of doses), overall amount of opioid
utilized, use of other concomitant medications, vital signs,
adverse events, length of surgery and time in
recovery.
"We are very interested in analyzing data from patients that
were administered DSUVIA across all types of plastic surgery
procedures. We have used DSUVIA for over a year in a wide variety
of cases and there are no currently published studies focusing on
plastic surgery with this sublingual analgesic, which has been a
major evolution for our practice," said Dr. Seify. "Evaluating the
safety, efficacy, and timing of dosing of DSUVIA for short cases in
awake patients, such as liposuction, as well as for more extensive
surgeries under general anesthesia, will allow other plastic
surgeons to benefit from our experience," continued Dr. Seify.
"Plastic surgery has been one of the fastest growing specialties
where DSUVIA is being used. Dr. Seify is a key thought-leader in
this specialty and he quickly understood the potential benefits of
DSUVIA for use for plastic surgical procedures," said Dr.
Pamela Palmer, co-founder and Chief
Medical Officer of AcelRx. "We look forward to the analysis and
publication of his clinical data with DSUVIA as plastic surgeons
are eager for alternatives to IV opioids when treating
moderate-to-severe acute pain."
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA®, known as DZUVEO® in
Europe, approved by the FDA in
November 2018, 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 in June
2018 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.
Forward-Looking Statements
This press
release contains forward-looking statements, including, but not
limited to, statements related to expected commencement of an
investigator-initiated study, the scope of the study, and expected
analysis and publication of clinical data. These and any other
forward-looking statements are made pursuant to the
safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. These statements may be identified by the use
of forward-looking terminology such as "believes," "expects,"
"anticipates," "may," "will," "should," "seeks," "approximately,"
"intends," "plans," "estimates," or the negative of these words or
other comparable terminology. The discussion of strategy, plans or
intentions may also include forward-looking statements. These
forward-looking statements involve risks and uncertainties that
could cause actual results to differ materially from those
projected, anticipated or implied by such statements. In addition,
such risks and uncertainties may include, but are not limited to,
those described in the Company's annual, quarterly and current
reports (i.e., Form 10-K, Form 10-Q and Form 8-K) as filed or
furnished with the Securities and Exchange Commission (SEC). You
are cautioned not to place undue reliance on any such
forward-looking statements, which speak only as of the date such
statements were first made. The Company's SEC reports are available
at www.acelrx.com under the "Investors" tab. Except to the extent
required by law, the Company undertakes no obligation to publicly
release the result of any revisions to these forward-looking
statements to reflect events or circumstances after the date
hereof, or to reflect the occurrence of unanticipated
events.
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SOURCE AcelRx Pharmaceuticals, Inc.