REDWOOD CITY, Calif.,
Nov. 19, 2015 /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, announced today that a moderated poster presentation
will be made at the Emerging Technology session of the American
Society of Regional Anesthesia and Pain Medicine (ASRA)
14th Annual Pain Medicine Meeting to be held
November 19th to
November 21st at the
Fontainebleau Miami Beach in Miami, Florida. The annual ASRA meeting
is the foremost scientific and educational event on invasive and
non-invasive targeted therapies in pain medicine and brings
together nearly 1,000 national and international thought leaders.
Pamela Palmer, M.D. Ph.D., AcelRx Co-founder and Chief
Medical Officer, will present safety and efficacy data from a Phase
3 trial, SAP301, evaluating the sufentanil sublingual 30 mcg
tablet, or ARX-04, for the treatment of acute pain following
ambulatory surgery.
Details on the presentation times are as follows:
Thursday, November 19, 2015 –
Emerging Technology Moderated Poster Session, MP-02, Presentation
time 10:45-12:45pm (local time),
Splash 13
Authors:
|
Harold Minkowitz, MD,
Shankar Lakshman, MD, Timothy Melson, MD, David Leiman, MD, Karen
DiDonato, MSN, RN and Pamela Palmer, MD, PhD
|
|
|
Title:
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Safety and Efficacy
Subgroup Analysis by Age of Sufentanil Sublingual 30 mcg Tablets
for the Treatment of Acute Pain following Outpatient Abdominal
Surgery
|
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
proposed treatment of moderate-to-severe acute pain in a medically
supervised setting; and Zalviso™ (sufentanil sublingual tablet
system) for the intended 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 (SAP-302) 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 and
initiation of a clinical study to support resubmission.
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 United States; 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 design and 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 November 3,
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.