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 acute pain, provided
guidance today on 2017 milestones for its lead product, ARX-04,
known as DSUVIA™ (sufentanil sublingual tablet, 30 mcg) in
the United States. Specifically,
AcelRx's corporate milestones for DSUVIA and ARX-04 in the upcoming
year are as follows:
- Advance the NDA. AcelRx submitted a 505(b)2 new drug
application (NDA) for DSUVIA for moderate-to-severe acute pain in a
medically supervised setting on December 12,
2016. The U.S. Food and Drug Administration (FDA) has 60
days to review an application and determine whether the NDA is
acceptable for filing. AcelRx expects to receive this notification
from the FDA in the first quarter of 2017. Assuming the FDA,
through the Division of Anesthesia, Analgesia and Addiction
Products (Division), accepts the NDA for filing, AcelRx will liaise
with the Division and any advisory committees that may be convened
during the review period.
- Submit the European Regulatory Application. AcelRx
expects to submit a Marketing Authorization Application (MAA) under
the Centralized Procedure for ARX-04 with the European Medicines
Agency (EMA) in the first half of 2017.
- Plan for U.S. Approval and Commercialization. Should the
Division favorably complete its review by the expected Prescription
Drug User Fee Act (PDUFA) date, AcelRx anticipates being prepared
to begin commercialization of DSUVIA as early as the fourth quarter
of 2017.
"The most significant goals we accomplished in 2016 were with
DSUVIA: The submission of the NDA; developing the DSUVIA
commercial strategy; and establishing the supply chain. As a
result, we are well positioned as we begin 2017 to advance DSUVIA
in the U.S. and ARX-04 in Europe,"
stated Howie Rosen, CEO of AcelRx.
"Of course, a positive FDA decision on our NDA has the potential to
fully transform AcelRx and allow us to begin commercialization of
DSUVIA into the emergency medicine market. As we presented in
December, we believe the peak revenue potential across all settings
for DSUVIA in the U.S. is $1.1
billion. This forecast also reinforced our comfort with
designating DSUVIA as our lead product and ZALVISO being a
potential follow-on product in the U.S."
Tim Morris, CFO of AcelRx added,
"We ended 2016 with $80 million in
cash and cash equivalents. We anticipate having about $50 million in cash at the end of the
2nd quarter of 2017. Our spending in the 2nd
half of 2017 will depend on the review process and PDUFA date set
by the Division as well as the specific details of our commercial
plans. The acceptance of the NDA for DSUVIA by April 1, 2017 also will allow us to refinance the
$21 million outstanding debt with
Hercules. We expect to provide cash guidance for the full year as
regulatory milestones and commercial plans become clearer."
Members of AcelRx senior management will be participating in The
Trout Group Annual 1x1 Management Access Event in San Francisco, January
10 – 13, 2017.
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, 30 mcg), 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; projected cash
balances; 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; the accuracy of our
cash projections; 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.