REDWOOD CITY, Calif., Nov. 9, 2016 /PRNewswire/ -- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced that it will host an Analyst & Investor Event in New York on Thursday, December 1, 2016, from 8:00am – 10:30am ET.
ARX-04 (sufentanil sublingual tablet, 30 mcg), for which AcelRx expects to file a New Drug Application (NDA) with the U.S. FDA by the end of 2016, will be the primary focus of the event. Gina Ford, vice president, commercial strategy at AcelRx, will present an overview of the market opportunity and the company's commercial plans for ARX-04. Harold Minkowitz, MD, an anesthesiologist at the Hermann Memorial City Medical Center in Houston, TX, will present an integrated summary of efficacy and safety data for ARX-04 and a review of the results of SAP302, the Phase 3 clinical trial of ARX-04 in the emergency room setting. In addition, an expert panel of doctors in emergency medicine will provide insights about unmet medical needs in the management of moderate-to-severe acute pain in the emergency room. The expert panel of doctors includes:
- John Holcomb, MD, FACS, professor and chief of acute care surgery at the University of Texas Health Science Center in San Antonio, TX and a colonel in the U.S. army who created comprehensive trauma systems for the Department of Defense;
- James Miner, MD, the chief of emergency medicine in the Hennepin County Medical Center in Minneapolis, MN; and,
- Michael Ritter, MD, an emergency medicine physician at the St. Joseph Health Mission Hospital in Mission Viejo, CA.
Senior members of the AcelRx management team will also be on hand to answer questions from analysts and investors.
Attendance at this event is by invitation only. For those not attending, a live webcast of the event can be accessed on the Investors page at www.acelrx.com, and a replay of the webcast will be archived there for 90 days.
For more information about the Analyst & Investor Event, please contact Patrick Till at [email protected].
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).
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 US. Grunenthal Group holds the rights for Zalviso in Europe, where a commercial launch has begun, and Australia, while AcelRx retains all other world-wide rights.
For additional information about clinical programs at AcelRx, please visit www.acelrx.com.
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.; 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; 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.
SOURCE AcelRx Pharmaceuticals, Inc.