REDWOOD CITY, Calif.,
Sept. 22, 2016 /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, today announced that Dr. Shankar Lakshman, a board-certified
plastic surgeon and AcelRx clinical investigator, will present a
subgroup analysis from the SAP301 study at the annual meeting of
the American Society of Plastic Surgeons (ASPS). SAP301 was a Phase
3 trial comparing placebo to ARX-04 (sufentanil sublingual tablet,
30 mcg) in 161 patients with moderate-to-severe acute pain
following ambulatory abdominal surgery. Dr. Lakshman's presentation
will focus on the reported activity of ARX-04 observed in the 80
patients who underwent abdominoplasty surgery. This cohort
demonstrated statistical significance vs placebo (31.8 vs 17.6;
p=0.001) for the primary efficacy endpoint of the summed pain
intensity difference to baseline over the 12-hour study period
(SPID-12). Nausea, headache and dizziness were the most commonly
reported adverse events in patients undergoing abdominoplasty and
the rates of occurrence were similar between active and placebo
treatment arms.
Details on the
presentation time are as follows:
|
Date:
|
Saturday, September
24, 2016 at 1:15 PM to 3:15 PM (local time)
|
Title:
|
Phase 3 Results of
Sublingual Sufentanil 30 mcg for the Management of Post-Operative
Pain Following Abdominoplasty Surgery
|
Authors:
|
Shankar Lakshman, MD
of Pasadena Surgeons in Pasadena, CA; Harold Minkowitz, MD of the
Memorial Hermann Memorial City Medical Center in Houston, TX;
Timothy Melson, MD of the Helen Keller Hospital in Sheffield, AL;
and David Leiman, MD of the Victory Medical Center in Houston,
TX
|
Plastic Surgery: The Meeting, the annual meeting of the American
Society of Plastic Surgeons (ASPS), brings together expert
aesthetic and reconstructive plastic surgeons to share their
knowledge and experience with colleagues from nearly 50 countries.
It is the premier educational and networking event of the year for
both domestic and international plastic surgeons. For more
information, please visit www.plasticsurgerythemeeting.com.
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 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.; anticipated resubmission of the
Zalviso NDA to the FDA; 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, including
anticipated submission of the ARX-04 NDA and the fact that the FDA
may dispute or interpret differently clinical results obtained from
the Phase 3 studies of ARX-04; AcelRx's ability to successfully
execute the pathway towards a resubmission of the Zalviso NDA to
the FDA; any delays or inability to obtain and maintain regulatory
approval of its product candidates including ARX-04 in the United States and Europe, and Zalviso in the United States; the uncertain clinical
development process, including adverse events; the risk that
planned clinical trials may not have an effective clinical design,
enroll a sufficient number of patients, or be completed on
schedule, if at all; 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
July 29, 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.