REDWOOD CITY, Calif.,
March 6, 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 agreement with Brigham and Women's
Hospital for an investigator-initiated study led by Richard D. Urman MD, MBA, Associate Professor of
Anesthesia and co-director of the Center for Perioperative Research
at Brigham and Women's Hospital and Harvard Medical School.
The study plans to examine the perioperative use of DSUVIA in the
analgesic regimen for spine surgery. Perioperative use of
DSUVIA in a prospective cohort of patients undergoing spine surgery
will be compared to historical controls. Analysis will
include whether DSUVIA is associated with a reduction in: pain
intensity in the recovery room, opioid consumption, number of IV
fentanyl boluses, opioid-induced side effects, and hospitalization
costs.
"An important part of our post-approval research strategy is to
obtain data from top-tier hospitals about the effectiveness of
DSUVIA in minimizing IV opioid administration while maintaining an
effective level of analgesia for the patient," said Dr.
Pamela Palmer, Co-Founder and Chief
Medical Officer at AcelRx Pharmaceuticals. "By supporting
investigator-initiated studies by highly respected institutions,
such as Brigham and Women's Hospital, we look to further test the
effectiveness, efficiency and safety of DSUVIA in a wide variety of
patients as well as its unique pharmacokinetic profile and
non-invasive route of administration. We believe DSUVIA will
soon become a key analgesic medication in the healthcare
practitioners' armamentarium 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.
For more information, 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.
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.