REDWOOD CITY, Calif.,
Oct. 24, 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 40th annual
National Conference on Correctional Health Care, which summarizes
findings from the Phase 3 SAP302 study of ARX-04 (sufentanil
sublingual tablet, 30 mcg) in patients who were admitted to the
emergency department with moderate-to-severe acute pain resulting
from trauma or injury. The National Conference on Correctional
Health Care will take place October 22-26,
2016 in Las Vegas, NV.
Details on the presentations are as follows:
Title:
|
Efficacy and Safety
of the Sufentanil Sublingual Tablet 30 mcg for Management of
Acute Traumatic Pain in the Emergency Department (Poster
#315)
|
Authors:
|
James Miner, MD of
the Hennepin County Medical Center in Minneapolis, MN; Harold
Minkowitz, MD of the Memorial Hermann Memorial City Medical Center
in Houston, TX; Zubaid Rafique, MD of Baylor College of Medicine in
Houston, TX; Sophia Sohoni, MD, Karen DiDonato, MSN, RN and Pamela
Palmer, MD, PhD of AcelRx Pharmaceuticals
|
About the National Conference on Correctional Health and the
Correctional System Population
There are approximately 1.5
million individuals housed in state and federal prisons, with 97%
sentenced for at least a one-year term. According to a 2007 study
published in the journal, Infection Control & Hospital
Epidemiology, correctional healthcare workers with clinical job
duties involving needles are at a higher risk for needle-stick
injury than healthcare workers in other settings.
Thousands of health professionals attend the National Conference
on Correctional Health Care, which is hosted by the National
Commission on Correctional Health Care. The NCCHC is committed to
improving the quality of health care in jails, prisons and juvenile
confinement facilities. For more information, please visit the
commission's website at www.ncchc.org.
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). Traditionally opioid pain
medication is delivered either through an intramuscular injection
or intravenously, both of which require a hypodermic needle. As a
sublingual formulation, ARX-04 requires no hypodermic needles to
administer. 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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SOURCE AcelRx Pharmaceuticals, Inc.