REDWOOD CITY, Calif.,
April 8, 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 investigator-initiated study at
Montefiore Medical Center evaluating the perioperative use of
DSUVIA (sufentanil sublingual tablet 30 mcg) for same-day surgical
procedures in patients on buprenorphine therapy for opioid-use
disorder or for chronic pain management.
The principal investigator, Dr. Naum Shaparin, is the Interim
Chair of the Department of Anesthesiology and Director of the
Multidisciplinary Pain Program at Montefiore Medical Center and
Professor of Anesthesiology at Albert Einstein College of Medicine.
The study will evaluate the efficacy and safety of DSUVIA for
perioperative management of surgical pain in patients on
buprenorphine treatment. Data from a total of 30 patients will be
evaluated for endpoints which include overall perioperative opioid
use, length of post-anesthesia care unit recovery time, outpatient
prescription opioid use over the first 24 hours after discharge
home, and adverse events. Data from these patients will be compared
to historical matched control patients on buprenorphine treated
with standard IV opioids in the perioperative setting.
"Buprenorphine is a partial opioid agonist, but it binds with
extremely high affinity to the mu-opioid receptor. When patients on
buprenorphine require a surgical procedure, they need the analgesic
efficacy of a full opioid agonist, but the opioids currently in use
have a lower receptor binding affinity and cannot displace the
partial agonist off the receptor, thereby limiting their effect,"
said Dr. Shaparin. "Sufentanil is unique in that it has a higher
binding affinity to the mu-opioid receptor than buprenorphine,
allowing DSUVIA to potentially provide these patients with more
effective analgesia, " continued Dr. Shaparin. Dr. Shaparin
previously served as a consultant for AcelRx and on advisory
boards.
"The buprenorphine-treated patient has long posed a clinical
challenge for anesthesiologists," said Dr. Pamela Palmer, co-founder and Chief Medical
Officer of AcelRx. "Being able to provide these patients a
perioperative analgesic option that may be more effective than
traditional IV opioids could be yet another way for DSUVIA to
advance acute pain management in medically supervised
settings."
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.
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, expected
analysis of clinical data, and the potential for DSUVIA to
provide buprenorphine-treated patients with
effective analgesia. 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.