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AcelRx Pharmaceuticals Presents Subgroup Analysis Demonstrating Positive Results of ARX‑04 by Type of Abdominal Surgery

TLPH | May 6, 2016

PR Newswire

REDWOOD CITY, Calif., May 6, 2016

REDWOOD CITY, Calif., May 6, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the Company and its investigators will be presenting a subgroup analysis of the Phase 3 SAP301 study results by surgery type (abdominoplasty, hernioplasty and laparoscopic abdominal surgery). SAP301 was a Phase 3 trial comparing ARX-04 (sufentanil sublingual 30 mcg tablet) to a placebo sublingual tablet in 163 patients with moderate-to-severe acute pain following ambulatory abdominal surgery. The analysis will be presented at the Society for Ambulatory Anesthesia (SAMBA) 31^st Annual Meeting, which is being held May 5-7, 2016 in Orlando, FL.

Details on the presentation time are as follows:
Date:	Saturday, May 7, 2016 at 12:00 – 1:30pm (local time)

Title:	Safety and Efficacy of Sufentanil Sublingual 30 mcg Tablets by Surgery Type for the Treatment of Acute Pain following Outpatient Abdominal Surgery

Authors:	Dr. Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Neil Singla, MD of Lotus Clinical Research in Pasadena, CA; Timothy Melson, MD of the Helen Keller Hospital in Sheffield, AL; David Leiman, MD of the Victory Medical Center in Houston, TX; and AcelRx Pharmaceuticals' Karen DiDonato, MSN, RN and Pamela P. Palmer, MD PhD

SAMBA provides a venue for anesthesiologists, anesthesia providers, practitioners, nurses and administrators who work and specialize in ambulatory or office-based anesthesia to learn about the latest clinical advances presented by experts in the field. For more information on the conferences, please visit www.sambahq.org.

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) designed for the treatment of moderate-to-severe acute pain in a medically supervised setting; and Zalviso™ (sufentanil sublingual tablet system) designed 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 studies in emergency room patients (SAP302) and post-operative patients 40 years and older (SAP303). 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 (IAP312), which AcelRx is planning to initiate once supplies are available, have been tested with acceptable results, and clinical sites are ready, in order to support its NDA 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, ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso™ (sufentanil sublingual tablet system), including the planned initiation of the IAP312 clinical trial for Zalviso; anticipated resubmission of the Zalviso NDA to the U.S. Food and Drug Administration, or FDA; and the therapeutic and commercial potential of AcelRx's product candidates, including ARX-04 and Zalviso. These forward-looking statements are based on AcelRx Pharmaceuticals' current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals' actual results and timing of events could differ materially from those anticipated in such forward-looking statements, and as a result of these risks and uncertainties, which include, without limitation, risks related to AcelRx Pharmaceuticals' ability to complete Phase 3 clinical development of ARX-04 and support ARX-04 development under the contract with the Department of Defense; AcelRx's ability to successfully execute the pathway towards a resubmission of the Zalviso NDA to the FDA, including the initiation and completion of the IAP312 clinical study for Zalviso; any delays or inability to obtain and maintain regulatory approval of its product candidates, including ARX-04 in the United States and Europe, and Zalviso in the United States; the uncertain clinical development process, including adverse events; the risk that planned clinical trials may not begin on time, have an effective clinical design, enroll a sufficient number of patients, or be initiated or completed on schedule, if at all; the success, cost and timing of all development activities and clinical trials, including the Phase 3 ARX-04 SAP302 and SAP303 trials, and the additional clinical trial for Zalviso, IAP312; the fact that the FDA may dispute or interpret differently clinical results obtained to date from the Phase 3 SAP301 study of ARX-04; the market potential for AcelRx's product candidates; and other risks detailed in the "Risk Factors" and elsewhere in AcelRx's U.S. Securities and Exchange Commission filings and reports, including its Annual Report on Form 10-Q filed with the SEC on May 2, 2016. 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.