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AcelRx Pharmaceuticals to Present Initial Results of Phase 3 Study of ARX‑04 at World Congress of Mountain & Wilderness Medicine

REDWOOD CITY, Calif., Aug 1, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the Company and its investigators will be presenting top-line results from the initial cohort of 40 patients in single-arm, open-label Phase 3 SAP302 study, which assessed ARX-04 (sufentanil sublingual tablet, 30 mcg) as a treatment for moderate-to-severe acute pain in adults who presented to the emergency department with trauma or injury. These data will be presented at the 7th World Congress of Mountain & Wilderness Medicine, which is taking place July 30 - August 4, 2016 at the Telluride Conference Center in Telluride, Colorado. Complete results from the SAP302 study will be presented at an upcoming medical meeting.

The AcelRx poster will be presented at the Congress by JohnRey Hassan, BSN, RN, a clinical nurse with the NorthBay Medical Center Emergency Department and a flight nurse with REACH Air Medical Services, an emergency service that provides air medical transports for critically ill and injured patients aboard medically equipped helicopters and airplanes. In addition, Mr. Hassan has worked as a paramedic for the National Parks Service at Yosemite & Yellowstone National Parks.

"As an emergency medicine nurse with career experience in the emergency department and pre-hospital services, both in urban and wilderness settings, JohnRey has unique insights into the challenges of providing analgesia for patients suffering with moderate-to-severe acute pain. This makes him an ideal presenter for these results at a conference dedicated to the treatment and rescue of injured climbers and other outdoor enthusiasts," added Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx Pharmaceuticals.

Details on the presentation time are as follows:

Date:      

Tuesday, August 2nd, 11:30am -12:10pm (local time)

Location:

Telluride Conference Center, Mountain Village East

Title:        

Phase 3 Efficacy and Safety Results of Sufentanil Sublingual 30 mcg Tablet for Management of Acute Traumatic Pain in Emergency Medicine

Authors: 

JohnRey Hassan, BSN, RN of NorthBay Medical Center, Fairfield, CA; James Miner, MD of the Hennepin County Medical Center in Minneapolis, MN; Harold Minkowitz, MD of the Memorial Hermann Memorial City Medical Center in Houston, TX; and AcelRx Pharmaceuticals' Karen DiDonato, MSN, RN and Pamela P. Palmer, MD, PhD

The World Congress of the Wilderness Medical Society attracts those working in wilderness medicine and providing care in challenging areas and extreme environments around the world. Topics such as improvised rescue techniques and disaster medicine will be presented by world experts in altitude medicine, wilderness medicine, mountain rescue and global/environmental medicine. For more information, please visit the congress website at www.wms.org/conferences/telluride.

About ARX-04
ARX-04 is a non-invasive investigational product candidate consisting of 30 mcg sufentanil tablets delivered sublingually via a disposable, pre-filled, single-dose applicator (SDA). AcelRx is developing ARX‑04 for the management of moderate-to-severe acute pain in a variety of medically supervised settings, including the emergency room, outpatient or ambulatory surgery, non-surgical patients experiencing pain in the hospital, and post-operative patients following short-stay surgery, who do not require more long-term patient-controlled analgesia (PCA).

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 recently completed enrollment of SAP302 (study in emergency room patients) and SAP303 (study in post-operative patients 40 years and older). 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 supply testing is complete 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 ARX-04 clinical trial results and the timing of such 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.; the anticipated timing, design and results of the IAP312 clinical trial for Zalviso; 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; 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' ability to complete Phase 3 clinical development of ARX-04; 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; 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 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.

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SOURCE AcelRx Pharmaceuticals, Inc.

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