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.