News Release

AcelRx Pharmaceuticals Presentation at JAB Burn Symposium Highlights Potential of DSUVIA™ for Use in Burn Victims with Moderate-to-Severe Acute Pain

REDWOOD CITY, Calif., Feb. 13, 2017 /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, announced an upcoming podium presentation of comprehensive results from the DSUVIA™ SAP302 study of patients who presented to emergency departments with moderate-to-severe acute pain resulting from trauma or injury, including burns. The presentation will take place at the annual John A. Boswick, M.D. (JAB) Burn and Wound Care Symposium February 12-16, 2017 in Maui, Hawaii.

Included in this presentation are case studies of a 26-year-old female with a second-degree burn of the anterior right thigh and a 49-year-old male with second and third-degree burns over 13% of his body. Both reported a baseline pain intensity of 8 on a validated 10-point scale and were administered DSUVIA as part of the SAP302 study in emergency room patients with moderate to severe acute pain.  After a single DSUVIA dose, each patient reported a 2-point decrease in pain intensity within 15 minutes. No adverse events were observed in either patient. In the SAP302 trial, the majority of patients experienced no adverse events. Among those who did experience side effects, the most commonly reported were nausea (9%), somnolence (5%) and vomiting (4%).  

According to the most recent National Hospital Ambulatory Care Survey, each year approximately 500,000 persons present to U.S. emergency departments with burns, and 40,000 are hospitalized.

Dr. Pamela Palmer, co-founder and chief medical officer at AcelRx, explained, "Tissue damage from a severe burn is one of the most painful and disfiguring forms of trauma. While opioids are the standard-of-care to address the moderate-to-severe acute pain from burns, damaged tissue can make intravenous (IV) access difficult. With a product like DSUVIA, emergency physicians would have the option to administer a non-invasive opioid that potentially provides patients analgesia within 15-30 minutes."

Details on the presentations are as follows:

Title:       

Safety and Efficacy of the Sufentanil Sublingual Tablet 30mcg (SST 30mcg) for Treatment of Moderate-to-Severe Acute Pain in the Emergency Department

Presenter: 

Karen DiDonato, MSN, RN of AcelRx Pharmaceuticals

Time/Place: 

Wednesday, February 15, 2017 at 8:30am

Clinical and Rehabilitative Medicine Research Program (CRMRP)
DSUVIA 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 DSUVIA (Formerly ARX-04)
DSUVIA 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.

DSUVIA is an investigational product candidate and is not approved in any geography.

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. An NDA for DSUVIA™ (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was submitted to the FDA for review in December 2016.

The Company's follow on product, ZALVISO® (sufentanil sublingual tablet system), designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting, is currently enrolling patients in a Phase 3 clinical trial, IAP312. 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 and is investigational and in late-stage development in the U.S. Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has begun.

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, DSUVIATM (sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside the United States, and ZALVISO® (sufentanil sublingual tablet system), including U.S. Food and Drug Administration, or FDA, review of the New Drug Application, or NDA, for DSUVIA; the potential approval of the DSUVIA NDA by the FDA; the DSUVIA and ARX-04 clinical trial results; AcelRx's pathway forward towards gaining approval of ZALVISO in the U.S., including successful completion of the IAP312 clinical study for ZALVISO; and the therapeutic and commercial potential of AcelRx's product candidates, including potential market opportunities for DSUVIA, 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' DSUVIA and ARX-04 development programs, including the FDA review of the DSUVIA NDA and the possibility that the FDA may dispute or interpret differently clinical results obtained from the DSUVIA Phase 3 studies; the ZALVISO development program, including successful completion of IAP312 and the resubmission of the ZALVISO NDA to the FDA; any delays or inability to obtain and maintain regulatory approval of its product candidates, including DSUVIA in the United States, ARX-04 in Europe and ZALVISO in the United States; the uncertain clinical development process; 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 November 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.

 

 

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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