REDWOOD CITY, Calif.,
Sept. 11, 2018 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the
Company), a specialty pharmaceutical company focused on innovative
therapies for use in medically supervised settings, today announced
the Anesthetic and Analgesic Drug Products Advisory Committee of
the U.S. Food and Drug Administration (FDA) has planned an Advisory
Committee meeting to review the Company's New Drug Application
(NDA) for DSUVIA for the management of moderate-to-severe acute
pain in medically supervised settings in adult patients.
"We have been actively preparing for this meeting since the
beginning of the year, and we're looking forward to sharing our
DSUVIA data with the Advisory Committee," said Dr. Pamela Palmer, Co-Founder and Chief Medical
Officer at AcelRx. "If approved, we believe that DSUVIA will
provide a novel non-invasive treatment option for
moderate-to-severe acute pain in medically supervised
settings."
The FDA accepted AcelRx's NDA in May 2018. The target
action date under the Prescription Drug User Fee Act (PDUFA) is
November 3, 2018.
About DSUVIA™ (sufentanil sublingual tablet), 30
mcg
DSUVIA™ (sufentanil sublingual tablet, 30
microgram), known as DZUVEO™ outside the
United States, has a proposed
indication for the management of moderate-to-severe acute
pain in medically supervised settings, in adult patients and was
designed to eliminate dosing errors associated with IV
administration via its non-invasive single-dose applicator (SDA)
administered by healthcare professionals. Sufentanil is an opioid
analgesic currently marketed for intravenous (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 Medicines Agency (EMA) approved DZUVEO
for marketing in Europe in
June 2018.
Clinical and Rehabilitative Medicine Research Program
(CRMRP)
DSUVIA™ is funded in part by the Clinical
and Rehabilitative Medicine Research Program (CRMRP) of
the U.S. Army Medical Research and Materiel Command
(USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was
established in 2008 to foster research and technology advances for
regeneration, restoration, and rehabilitation of traumatic
injuries. In accordance with USAMRMC guidelines, in the conduct of
clinical research, AcelRx has adhered to the policies regarding the
protection of human subjects as prescribed by Code of Federal
Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1,
Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human
Subjects).
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 two
product candidates including DSUVIA™ (sufentanil
sublingual tablet, 30 mcg), known as DZUVEO™ in
Europe, with a proposed indication
for the treatment of moderate-to-severe acute pain in medically
supervised settings, and Zalviso® (sufentanil sublingual
tablet system, SST system, 15 mcg) 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's clinical programs,
please visit www.acelrx.com.
Forward-Looking Statements
This press release
contains forward-looking statements, including, without limitation,
statements related to the process and timing of the FDA review of
the DSUVIA™ NDA resubmission, and the potential for
DSUVIA to provide a novel non-invasive treatment option for
moderate to severe acute pain in medically supervised settings.
These forward-looking statements are based on AcelRx's current
expectations and involve significant risks and uncertainties.
AcelRx's actual results and timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of these risks and uncertainties, including,
without limitation: risks related to the possibility that the data
supporting AcelRx's DSUVIA NDA resubmission may be disputed or
interpreted differently by the FDA such that it results in further
required action by the Company or ultimately does not support
approval; any delays or the inability to obtain and maintain
regulatory approval of DSUVIA in the
United States, and other risks detailed in the "Risk
Factors" and elsewhere in AcelRx's U.S. Securities and Exchange
Commission filings and reports, including its Annual Report on Form
10-K filed with the SEC on March 9,
2018 and Quarterly Report on Form 10-Q filed with the SEC on
August 2, 2018. AcelRx undertakes no
duty or obligation to update any forward-looking statements
contained in this release as a result of new information, future
events or changes in its expectations, except as required by
law.
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SOURCE AcelRx Pharmaceuticals, Inc.