REDWOOD CITY, Calif., Nov. 28, 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, has announced an update to the agenda for its December 1, 2016 Analyst & Investor Event. Dr. Nathaniel Katz, CEO of Analgesic Solutions and Adjunct Assistant Professor at Tufts University along with Dr. David Leiman, president of AIPM of Houston and Director of HD Research Corp., have been added to the agenda to offer their insights into the ARX-04 clinical program, regulatory pathway, market opportunity and the current treatment of acute pain.
Full Agenda of Expert Speakers
- Nathaniel Katz, MD; CEO of Analgesic Solutions, Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine;
- David Leiman, MD; President of AIPM of Houston and Director of HD Research Corp.;
- John Holcomb, MD; Chief of the Division of Acute Care Surgery, University of Texas Health Science Center, Houston, TX;
- James Miner, MD; Chief of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN; and
- Michael Ritter, MD Emergency Medicine Physician, St. Joseph Health Mission Hospital, Mission Viejo, CA.
Dr. Katz is considered to be one of the leading experts on the treatment of pain and the design of clinical trials to assess pain therapies. He founded Analgesic Solutions in 2007 with the aim of modernizing the design and conduct of pain clinical trials, to advance the scientific quality of clinical research, and to empower effective treatments for patients. Dr. Katz is also an Adjunct Assistant Professor of Anesthesia at Tufts University School of Medicine. Dr. Katz was previously chair of the Advisory Committee, Anesthesia, Critical Care and Addiction Products Division of the FDA. During the Analyst & Investor Event, Dr. Katz will provide his insights into the approval pathway for opioids.
Dr. Leiman founded and operates AIPM of Houston, a company that provides anesthesia and interventional pain services, and is Director of HD Research Corp., a company that specializes in inpatient acute pain clinical research. He has been involved in the ARX-04 clinical program and will present an integrated summary of efficacy and safety along with a review of the clinical results from the emergency room study, SAP302. Dr. Leiman replaces Dr. Harold Minkowitz, who was previously announced as a speaker.
The event will be webcast live and can be accessed through the Investors webpage at www.acelrx.com. For those not available to listen to the live broadcast, a replay will be archived for 90 days. For more information or to reserve a seat, please contact Patrick Till at [email protected]. Attendance at this event is by invitation only.
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 U.S. 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 AcelRx's clinical programs, 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.