REDWOOD CITY, Calif.,
Oct. 6, 2015 /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
and breakthrough pain, today announced the initiation of an
open-label Phase 3 study (SAP302) of ARX-04 for the treatment of
adult patients who present in the emergency room with
moderate-to-severe acute pain associated with trauma or injury. The
primary efficacy endpoint is the summed pain intensity difference
(SPID) over 1-hour (SPID1). Safety endpoints, such as adverse
events and vital signs will also be assessed, as will the patients'
and healthcare providers' satisfaction with the method of pain
control. The study is expected to be completed in early 2016.
"In our recently concluded SAP301 study, ARX-04 was shown to
provide a rapid onset of action within 15 minutes of
administration, making it well-suited for use in an emergency room
setting, where speed is critical and where access to intravenous
morphine may not be immediately available," stated Dr. Pamela Palmer, co-founder and chief medical
officer of AcelRx Pharmaceuticals. "The SAP302 study is intended to
provide us with valuable insights into the optimal use of ARX-04 in
the emergency room setting, one of our initial target markets. It
is also intended to complete the safety database requirements
previously agreed to with the FDA."
Howie Rosen, interim CEO of
AcelRx, added, "As part of our development program, we expect to
meet with the U.S. Food and Drug Administration to review plans for
a New Drug Application for ARX-04 and will provide more guidance on
regulatory timing following that meeting."
About ARX-04
ARX-04 is a non-invasive investigational
product candidate consisting of 30 mcg sufentanil tablets delivered
sublingually via a disposable, pre-filled, single-dose applicator
(SDA). AcelRx is developing ARX‑04 for the management of
moderate-to-severe acute pain in a variety of medically supervised
settings, including the emergency room, outpatient or ambulatory
surgery, non-surgical patients experiencing pain in the hospital,
and post-operative patients following short-stay surgery, who do
not require more long-term patient-controlled analgesia (PCA).
ARX-04 development is funded in part by the US Army Medical
Research and Materiel Command (USAMRMC).
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 acute pain. The company's late-stage pipeline
includes ARX-04 (sufentanil sublingual tablet, 30 mcg) for the
treatment of moderate-to-severe acute pain in a medically
supervised setting; and Zalviso™ (sufentanil sublingual tablet
system) for the management of moderate-to-severe acute pain in
adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index
opioid, sublingually through a disposable, pre-filled, single-dose
applicator. AcelRx has reported positive results from the pivotal
Phase 3 SAP301 ambulatory surgery study, and has advanced
ARX-04 into a study in emergency room patients. Zalviso delivers 15
mcg sufentanil sublingually through a non-invasive delivery route
via a pre-programmed, patient-controlled analgesia device. In
response to the New Drug Application (NDA) AcelRx submitted to the
U.S. Food and Drug Administration (FDA) seeking approval for
Zalviso, AcelRx received a Complete Response Letter (CRL) on
July 25, 2014. The FDA has requested
an additional clinical study and the Company is working with the
FDA regarding the resubmission of the Zalviso NDA.
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,
including the process and timing of anticipated future development
of Zalviso and ARX-04; anticipated results and timing of the
completion of SAP302 study for ARX-04; the therapeutic and
commercial potential of AcelRx product candidates, including
Zalviso and ARX-04; AcelRx's plans to seek a pathway forward
towards gaining approval of Zalviso in the US; and anticipated
resubmission of the Zalviso NDA to the FDA, including the scope and
timing of resubmission. These forward-looking statements are based
on AcelRx's current expectations and inherently involve significant
risks and uncertainties. AcelRx's actual results and the timing of
events could differ materially from those anticipated in such
forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to:
any delays or inability to obtain and maintain regulatory approval
of its product candidates, including Zalviso and ARX-04; the market
potential for its product candidates, including Zalviso and ARX-04,
in the United States and
Europe; its ability to timely
resubmit the Zalviso NDA to the FDA and to receive regulatory
approval for Zalviso; the fact that the FDA may dispute or
interpret differently positive clinical results obtained to date
from the pivotal Phase 3 SAP301 ambulatory surgery study of ARX-04;
its ability to complete Phase 3 clinical development of ARX-04; the
success, cost and timing of all product development activities and
clinical trials, including the SAP302 ARX-04 trial; 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
August 4, 2015. 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.