REDWOOD CITY, Calif.,
Oct. 31, 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, announced an upcoming poster presentation at The Obesity
Society Annual Meeting, which is taking place October 31 - November 4, 2016 in New Orleans, LA.
This poster presents data that shows that obese patients treated
with ARX-04 (sufentanil sublingual tablet, 30 mcg) in the Phase 3
SAP301 study following ambulatory abdominal surgery experienced
greater pain relief over the 12-hour study period (SPID-12)
compared to those treated with a placebo. The experience of obese
patients in the study was similar to that of patients with lower
BMIs. Nausea (23%) and headache (10%) were the only adverse events
reported by more than one patient in the obese cohort treated with
ARX-04. Overall, while sample sizes were limited, the conclusion of
this analysis was that safety and efficacy results were consistent
across the entire study population, regardless of BMI.
Details on the
presentations are as follows:
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Date:
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Friday, November
4th, 12:00 – 1:30 p.m. (local time)
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Title:
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The Sufentanil
Sublingual 30mcg Tablet and Effect of BMI on Post-Operative Pain
Management Following Outpatient Abdominal Surgery
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Authors:
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Harold Minkowitz, MD
of the Memorial Hermann Memorial City Medical Center in Houston,
TX; Shankar Lakshman, MD of Lotus Clinical Research in Pasadena,
CA; Timothy Melson, MD of the Helen Keller Hospital in Sheffield,
AL; David Leiman, MD of the Victory Medical Center in Houston, TX;
and Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD of AcelRx
Pharmaceuticals
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Dr. Pamela Palmer, chief medical
officer and co-founder of AcelRx added, "Obese patients require
careful weight-based dosing regimens when using many opioid pain
medications, such as morphine. The evidence from this study
suggests that ARX-04 has the potential for fixed-dose pain
management for these patients."
ObesityWeek is a unique, international event focused on the
basic science, clinical application, surgical intervention and
prevention of obesity. By combining both American Society for
Metabolic & Bariatric Surgery (ASMBS) and The Obesity Society
(TOS) annual meetings, ObesityWeek brings together world-renowned
experts in obesity to share innovation and breakthroughs in science
unmatched around the globe. Attendees will enjoy the diverse
educational opportunities, networking events, and scientific
synergies created through the collaboration of these leading
obesity organizations. More information may be found at
http://obesityweek.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 resubmission of the
Zalviso NDA; 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 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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visit:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-to-present-arx-04-analysis-for-treatment-of-moderate-to-severe-acute-pain-in-obese-patients-at-the-obesity-society-annual-meeting-300353649.html
SOURCE AcelRx Pharmaceuticals, Inc.