REDWOOD CITY, Calif.,
Oct. 9, 2015 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that a
presentation will be made at the annual European Society of
Emergency Medicine (EuSEM) meeting to be held October 11thth to October 14th, 2015 at the Lingotto
Congress Centre in Turin, Italy.
The annual EuSEM is the largest meeting of emergency medicine
practitioners in the world with over 2000 delegates in attendance
and 90 countries represented.
The presentation marks the first time top-line results from the
recently completed phase 3 study using sublingual sufentanil 30mcg
tablets for the management of moderate to severe acute pain in
outpatient abdominal surgery patients, or SAP301, will be revealed
to the academic and scientific community. Data from the
previously announced phase 2 bunionectomy trial will also be
included. Both studies were multi-center, randomized,
double-blind and placebo-controlled.
Details on the presentation time are as follows:
Monday, October 12 and
Tuesday, October 13, 2015 –
Participants will be able to watch the eposters freely on LCD
screens throughout the Exhibit Hall and browse them using a tactile
computer linked to the screen - Presentation time 9:00am-4:00pm (local time).
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Authors:
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Neil Singla, MD;
Derek Muse, MD; Harold Minkowitz, MD; Shankar Lakshman, MD;
Karen DiDonato, MSN, RN; Pamela Palmer, MD, PhD
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Title:
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Efficacy and
Safety of Sublingual Sufentanil 30mcg for the Management of Acute
Pain
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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, 30mcg) 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 30mcg 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 (SAP302) in emergency room patients. 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 as well as Norway, Iceland and Liechtenstein and is in late-stage development
in the U.S. AcelRx submitted a New Drug Application (NDA) for
Zalviso and received a Complete Response Letter (CRL) from the FDA
on July 25, 2014. The FDA
subsequently requested an additional clinical study to evaluate the
effectiveness of product changes made in response to the CRL, and
the Company is working with the FDA regarding the resubmission of
the Zalviso NDA and initiation of a clinical study to support
resubmission.
The Company has two additional pain treatment product
candidates, ARX-02 and ARX-03, which have completed Phase 2
clinical development. 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 the SAP302 study for ARX-04; AcelRx's plans to seek a
pathway forward towards gaining approval of Zalviso in the U.S.;
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; its
ability to successfully complete the additional clinical study
requested by the FDA to support resubmission of the Zalviso NDA;
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.