REDWOOD CITY, Calif.,
Sept. 22, 2020 /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 that the U.S. Army has awarded
AcelRx with an initial contract of up to approximately $3.6 million for the purchase of DSUVIA to
support a study to aid the development of clinical practice
guidelines. Orders under the contract may be fulfilled over
the next four years as specified in the agreement, with an initial
purchase expected this year.
"We are excited to receive this initial contract award for
DSUVIA, which exemplifies the continued momentum with the
Department of Defense," said Vince
Angotti, Chief Executive Officer at AcelRx Pharmaceuticals.
"This award is in addition to expected purchases from the U.S. Army
for the initial stocking of their medical assemblages, sets, kits
and outfits for troop deployment, as well as potential orders from
other branches of the military following the recent approval of
DSUVIA onto the Joint Deployment Formulary. We believe that
DSUVIA's unique pharmacokinetic profile, high therapeutic index,
and efficient sublingual delivery will position it as a key option
for acute pain management across all branches of the military,"
continued Mr. Angotti.
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
the expected purchasing of DSUVIA by the military and DSUVIA being
positioned as a key option for acute pain management across
all branches of the military. 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.