REDWOOD CITY, Calif.,
Nov. 13, 2014 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain today announced that a moderated poster
presentation will be made at the American Society of Regional
Anesthesia and Pain Medicine (ASRA) 13th Annual
Pain Medicine Meeting to be held November 13th to November 16th, 2014 at the Hyatt
Regency in San Francisco,
CA. The annual ASRA meeting is the foremost scientific and
educational event on invasive and non-invasive targeted therapies
in pain medicine and brings together over 900 national and
international thought leaders. Pamela
Palmer, M.D. Ph.D. will present safety and efficacy data
from a Phase 3 pivotal trial evaluating the Zalviso sufentanil
sublingual tablet system for the treatment of moderate-to-severe
acute pain following joint replacement surgery.
Details on the presentation time are as follows:
Thursday, November 13, 2014 –
Acute Pain Moderated e-Poster Session 1, Pacific Foyer on the
Pacific Concourse level, Poster #ASRAP-0128 – Presentation
time 3:00-4:30pm (local time).
Authors:
|
Harold Minkowitz, MD,
Maurice Jove, MD and Pamela P. Palmer, MD, PhD
|
|
|
Title:
|
DEMOGRAPGHIC
SUBPOPULATION ANALYSIS OF PAIN INTENSITY REDUCTION WITH SUFENTANIL
SUBLINGUAL TABLET SYSTEM FOLLOWING JOINT REPLACEMENT SURGERY – A
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
|
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 and breakthrough
pain. AcelRx's lead product candidate, Zalviso, is designed
to improve the management of moderate-to-severe acute pain in adult
patients in the hospital setting by utilizing a high therapeutic
index opioid, through a non-invasive delivery route via a
pre-programmed, patient-controlled analgesia device. AcelRx has
announced positive results from each of the three completed Phase 3
clinical trials for Zalviso, and has submitted an NDA to the FDA
seeking approval for Zalviso in the treatment of moderate-to-severe
acute pain in adult patients in the hospital setting and on
July 25th, received a Complete
Response Letter from the FDA. AcelRx plans to initiate a
Phase 3 clinical trial for ARX-04, a product candidate for the
treatment of moderate-to-severe acute pain in a medically
supervised setting. 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 company's
Zalviso NDA and the Complete Response Letter, or CRL, the recent
meeting held with the FDA to discuss the CRL, our plans to address
the issues raised in the CRL, our anticipated resubmission of the
Zalviso NDA to the FDA, including the scope of the resubmission and
the timing of the resubmission and FDA review time, planned
initiation of the Phase 3 clinical trial for ARX-04, and the
therapeutic and commercial potential of AcelRx Pharmaceuticals'
product candidates, including Zalviso. These forward-looking
statements are based on AcelRx Pharmaceuticals' current
expectations and inherently involve significant risks and
uncertainties. AcelRx Pharmaceuticals' 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:
AcelRx Pharmaceuticals' ability to receive regulatory approval for
Zalviso; any delays or inability to obtain and maintain regulatory
approval of its product candidates, including Zalviso, in
the United States and Europe; AcelRx's ability to build an effective
commercial organization; its ability to obtain sufficient financing
to commercialize Zalviso and proceed with clinical development of
ARX-04; the success, cost and timing of all product development
activities and clinical trials, including the planned Phase 3
ARX-04 trial; the market potential for its product candidates; and
other risks detailed in the "Risk Factors" and elsewhere in AcelRx
Pharmaceuticals' U.S. Securities and Exchange Commission filings
and reports, including its Quarterly Report on Form 10-Q filed with
the SEC on November 10, 2014. AcelRx
Pharmaceuticals 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.
Logo -
http://photos.prnewswire.com/prnh/20130226/MM67303LOGO
SOURCE AcelRx Pharmaceuticals, Inc.