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AcelRx Pharmaceuticals Announces Zalviso™ Sublingual Sufentanil Data Presentation At The American Society Of Regional Anesthesia And Pain Medicine Meeting

Data from Sublingual Sufentanil Tablet System Development Program Highlights Efficacy across Various Demographic Populations

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. 

AcelRx logo.

Logo - http://photos.prnewswire.com/prnh/20130226/MM67303LOGO

SOURCE AcelRx Pharmaceuticals, Inc.

Timothy E. Morris, Chief Financial Officer, 650.216.3511, tmorris@acelrx.com; Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com