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Findings from AcelRx Pharmaceuticals' Phase 3 SAP301 Study of ARX-04 in Abdominoplasty Patients to be Presented at Plastic Surgery Meeting

TLPH | September 22, 2016

PR Newswire

REDWOOD CITY, Calif., Sept. 22, 2016

REDWOOD CITY, Calif., Sept. 22, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, today announced that Dr. Shankar Lakshman, a board-certified plastic surgeon and AcelRx clinical investigator, will present a subgroup analysis from the SAP301 study at the annual meeting of the American Society of Plastic Surgeons (ASPS). SAP301 was a Phase 3 trial comparing placebo to ARX-04 (sufentanil sublingual tablet, 30 mcg) in 161 patients with moderate-to-severe acute pain following ambulatory abdominal surgery. Dr. Lakshman's presentation will focus on the reported activity of ARX-04 observed in the 80 patients who underwent abdominoplasty surgery. This cohort demonstrated statistical significance vs placebo (31.8 vs 17.6; p=0.001) for the primary efficacy endpoint of the summed pain intensity difference to baseline over the 12-hour study period (SPID-12). Nausea, headache and dizziness were the most commonly reported adverse events in patients undergoing abdominoplasty and the rates of occurrence were similar between active and placebo treatment arms.

Details on the presentation time are as follows:
Date:	Saturday, September 24, 2016 at 1:15 PM to 3:15 PM (local time)
Title:	Phase 3 Results of Sublingual Sufentanil 30 mcg for the Management of Post-Operative Pain Following Abdominoplasty Surgery
Authors:	Shankar Lakshman, MD of Pasadena Surgeons in Pasadena, CA; Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; Timothy Melson, MD of the Helen Keller Hospital in Sheffield, AL; and David Leiman, MD of the Victory Medical Center in Houston, TX

Plastic Surgery: The Meeting, the annual meeting of the American Society of Plastic Surgeons (ASPS), brings together expert aesthetic and reconstructive plastic surgeons to share their knowledge and experience with colleagues from nearly 50 countries. It is the premier educational and networking event of the year for both domestic and international plastic surgeons. For more information, please visit www.plasticsurgerythemeeting.com.

Clinical and Rehabilitative Medicine Research Program (CRMRP)
ARX-04 is funded in part by the Clinical and Rehabilitative Medicine Research Program (CRMRP) of the U.S. Army Medical Research and Materiel Command (USAMRMC) under contract No. W81XWH-15-C-0046. The CRMRP was established in 2008 to foster research and technology advances for regeneration, restoration, and rehabilitation of traumatic injuries.

In accordance with USAMRMC guidelines, in the conduct of clinical research, AcelRx has adhered to the policies regarding the protection of human subjects as prescribed by Code of Federal Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1, Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human Subjects).

About ARX-04
ARX-04 is a non-invasive investigational product candidate consisting of 30-mcg sufentanil tablets delivered sublingually by a healthcare professional using a disposable, pre-filled, single-dose applicator (SDA). Sufentanil is a synthetic opioid analgesic with a high therapeutic index and no known active metabolites.

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 moderate-to-severe 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 medically supervised settings; and Zalviso® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting. 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 investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for Zalviso in Europe and Australia, while AcelRx retains all other world-wide rights.

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 ARX-04 clinical trial results; anticipated submission of the New Drug Application, or NDA, for ARX-04 to the U.S. Food and Drug Administration, or FDA; AcelRx's pathway forward towards gaining approval of Zalviso in the U.S.; anticipated resubmission of the Zalviso NDA to the FDA; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for 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' ARX-04 development program, including anticipated submission of the ARX-04 NDA and the fact that the FDA may dispute or interpret differently clinical results obtained from the Phase 3 studies of ARX-04; AcelRx's ability to successfully execute the pathway towards a resubmission of the Zalviso NDA to the FDA; 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 have an effective clinical design, enroll a sufficient number of patients, or be completed on schedule, if at all; the success, cost and timing of all development activities and clinical trials; 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 July 29, 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.