REDWOOD CITY, Calif.,
March 10, 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 confirmation that the Department of
Defense Milestone C meeting will be held next month. The
Milestone C meeting marks the end of the project development phase
and leads to the recommendation for the procurement phase of the
project.
"We are excited to have a confirmed date for the Milestone C
meeting and expect DSUVIA® will soon be made available more
broadly for military use," said Vince
Angotti, Chief Executive Officer of AcelRx
Pharmaceuticals. "The Department of Defense has been a great
partner supporting the development of DSUVIA since 2011, and this
is the final stage in the process that enables us to provide DSUVIA
to fulfill an unmet need for our injured soldiers," continued
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.
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 the timing of the Department of Defense
Milestone C meeting and anticipated procurement by 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. 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 AcelRx'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. AcelRx's SEC reports are available at
www.acelrx.com under the "Investors" tab. Except to the extent
required by law, AcelRx 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.