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AcelRx Pharmaceuticals Presents Efficacy and Pharmacokinetics of DSUVIA™ at Upcoming Congresses

REDWOOD CITY, Calif., March 16, 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, will present data from the DSUVIA™ (sufentanil sublingual tablet, 30 mcg) clinical program at two upcoming medical meetings. On March 16, 2017, during the annual meeting of the American Academy of Pain Medicine, AcelRx will present a poster from SAP101 comparing the pharmacokinetics of DSUVIA to that of an intravenous (IV) infusion of Sufenta® (sufentanil citrate injection, 30 mcg). On March 21, 2017, AcelRx will present safety and efficacy findings from SAP302 during the International Symposium on Intensive Care and Emergency Medicine being held in Brussels. SAP302 was an open-label Phase 3 trial conducted in 76 adult patients who present to the emergency department with moderate-to-severe acute pain associated with trauma or injury.

Details on the presentations are as follows:

Meeting: 

American Academy of Pain Medicine

Title: 

Pharmacokinetics of a Single Dose of Sufentanil Sublingual Tablet 30 mcg vs Intravenous Sufenta® 30 mcg (50 mcg/mL) Infused over 1 Minute in Healthy Volunteers

Authors: 

Sandra Willsie, DO, MA; Karen DiDonato, MSN, RN; Pamela P. Palmer, MD, PhD

Time/Date: 

6:00pm on March 16th – 11:00am on March 17th

 

Meeting: 

International Symposium on Intensive Care and Emergency Medicine

Title: 

Safety and Efficacy of the Sufentanil Sublingual Tablet 30 mcg for Management of Acute Traumatic Pain

Authors: 

James Miner, MD; Riccardo Leto, MD; Zubaid Rafique, MD; Francesco Della Corte, MD

Time/Date:

6:00pm on March 21st

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, 30mcg) with a proposed indication for the treatment of moderate-to-severe acute pain in medically supervised settings, was accepted for filing by the FDA.

The Company's follow on product candidate, 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; 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 Annual Report on Form 10-K filed with the SEC on March 3, 2017. 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, OR Brian Korb, The Trout Group LLC, 646.378.2923, bkorb@troutgroup.com