REDWOOD CITY, Calif.,
Jan. 8, 2017 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
moderate-to-severe acute pain, announced that the U.S. Food and
Drug Administration (FDA) has conditionally accepted the brand
name, DSUVIA™ (sufentanil sublingual tablet, 30 mcg), for the
company's investigational product candidate, ARX-04. In addition,
AcelRx has applied to the U.S. Patent and Trademark Office to
obtain federal registration of the DSUVIA mark.
AcelRx recently announced the submission of a New Drug
Application (NDA) with the FDA for DSUVIA for the treatment of
patients experiencing moderate-to-severe acute pain in a medically
supervised setting. This market is comprised of the adult emergency
department setting, ambulatory and outpatient surgical settings,
short-stay inpatient settings and certain office settings that
serve patients undergoing painful procedures. In total, based on
internal market research and published national surveys, AcelRx
expects the peak market for DSUVIA in the U.S. to be an estimated
$1.1 billion.
"Our initial target market will be the emergency medicine
market," commented Gina Ford,
AcelRx's vice president of commercial strategy. "Pending a
favorable review by the FDA, we anticipate initiating a pilot
launch program into identified centers of excellence around the
country shortly after approval. During the next three quarters, we
plan to add the necessary commercial staff and infrastructure to
support these initial commercialization efforts."
The FDA is expected to determine by mid-February 2017 whether the DSUVIA NDA is
complete and acceptable for review. Should the Agency accept the
NDA for review, a Prescription Drug User Fee Act (PDUFA) decision
could be expected in the fourth quarter of 2017.
About DSUVIA (formerly known as ARX-04)
DSUVIA is a
non-invasive investigational product candidate consisting of 30 mcg
sufentanil tablets delivered sublingually by a healthcare
professional using a disposable, pre-filled, single-dose applicator
(SDA). Sufentanil is a synthetic opioid analgesic with a high
therapeutic index and no known active metabolites.
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 the treatment of moderate-to-severe acute pain. An NDA for
DSUVIA (sufentanil sublingual tablet, 30mcg), known as ARX-04
outside the United States, with a
proposed indication for the treatment of moderate-to-severe acute
pain in medically supervised settings, was recently submitted to
the FDA for review.
The Company's follow on product, ZALVISO® (sufentanil sublingual
tablet system), designed for the management of moderate-to-severe
acute pain in adult patients in the hospital setting, is currently
enrolling patients in a Phase 3 clinical trial, IAP312. ZALVISO
delivers 15 mcg sufentanil sublingually through a non-invasive
delivery route via a pre-programmed, patient-controlled analgesia
device. ZALVISO is approved in the EU and is investigational and in
late-stage development in the U.S. Grunenthal Group holds the
rights for ZALVISO in Europe,
where a commercial launch has begun.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
Forward-Looking Statements
This press
release contains forward-looking statements, including, but not
limited to, statements related to the process and timing of
anticipated future development of AcelRx's product candidates,
DSUVIATM (sufentanil sublingual tablet, 30 mcg), known
as ARX-04 outside the United
States, and ZALVISO (sufentanil sublingual tablet system),
including U.S. Food and Drug Administration, or FDA, review of the
New Drug Application, or NDA, for DSUVIA; the potential
approval of the DSUVIA NDA by the FDA; the DSUVIA and ARX-04
clinical trial results; AcelRx's pathway forward towards gaining
approval of ZALVISO in the U.S., including successful completion of
the IAP312 clinical study for ZALVISO; and the therapeutic and
commercial potential of AcelRx's product candidates, including
potential market opportunities and market size for DSUVIA, ARX-04
and ZALVISO. These forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx Pharmaceuticals' actual
results and timing of events could differ materially from those
anticipated in such forward-looking statements, and as a result of
these risks and uncertainties, which include, without limitation,
risks related to AcelRx Pharmaceuticals' DSUVIA and ARX-04
development programs, including the FDA review of the DSUVIA NDA
and the possibility that the FDA may dispute or interpret
differently clinical results obtained from the DSUVIA Phase 3
studies; the ZALVISO development program, including successful
completion of IAP312 and the resubmission of the ZALVISO NDA to the
FDA; any delays or inability to obtain and maintain regulatory
approval of its product candidates, including DSUVIA in
the United States, ARX-04 in
Europe and ZALVISO in the United States; the uncertain clinical
development process; the success, cost and timing of all
development activities and clinical trials; actual market size for
AcelRx product candidates; and other risks detailed in the "Risk
Factors" and elsewhere in AcelRx's U.S. Securities and Exchange
Commission filings and reports, including its Quarterly Report on
Form 10-Q filed with the SEC on November 2,
2016. 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.
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SOURCE AcelRx Pharmaceuticals, Inc.