REDWOOD CITY, Calif.,
Aug. 24, 2020 /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
with Cleveland Clinic. The study will assess the effects of
DSUVIA on post-operative recovery from orthopedic surgery.
"A recently published study and preliminary data from other
open-label studies using DSUVIA in the perioperative environment
suggest a substantial decline in the amount of opioids used in the
PACU, and a dramatic decrease in time to discharge from the PACU
with DSUVIA-treated patients compared to historical controls,"
states Dr. Pamela Palmer, Co-Founder
and Chief Medical Officer at AcelRx Pharmaceuticals. "By supporting
investigator-initiated, double-blind studies conducted at highly
respected institutions, we look to further demonstrate the benefits
of DSUVIA in the intra- and post-operative environment. We also
look forward to additional studies of the effectiveness, efficiency
and safety of DSUVIA in settings outside the post-surgical arena.
We strongly believe the findings from all of these trials
will further support DSUVIA becoming a key analgesic medication for
the management of acute pain in medically supervised settings,"
continued Dr. Palmer.
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 and the scope of the study, expected
findings from the investigator-initiated study and other studies,
and the expected commencement of additional studies. 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.