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 ptill@troutgroup.com. 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).
About ARX-04
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.
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; 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.
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SOURCE AcelRx Pharmaceuticals, Inc.