REDWOOD CITY, Calif.,
Sept. 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
moderate-to-severe acute pain, today announced that the Company and
investigators will be presenting two e-posters at the European
Congress on Emergency Medicine (ECEM), which is being held
October 1-5, 2016 in Vienna, Austria. Both e-posters will be
displayed on monitors throughout the meeting, and will be available
following the conclusion of the conference on the AcelRx
Publications webpage.
The first presentation summarizes the safety and efficacy
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 an injury or trauma associated with
moderate-to-severe acute pain. Results from this trial showed
substantial reductions in pain intensity (mean 2.9 out of 10 on a
validated pain scale) within the first hour among the 76 patients
treated with ARX-04. The second e-poster provides insights into the
direct and indirect (labor, pharmacy, etc.) costs associated with
the administration of intravenous (IV) opioids. Based on an
analysis of over 600 hospitals, AcelRx has determined that an
initial IV dose of an opioid, such as morphine, hydromorphone and
fentanyl, ranges from $143 to $145 in
U.S. emergency departments.
Details on the
presentations are as follows:
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1.
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Title:
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Efficacy and Safety
of Sufentanil Sublingual Tablet 30 mcg for Management of Acute
Traumatic Pain in the Emergency Department
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Authors:
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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; and Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD
of AcelRx Pharmaceuticals
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2.
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Title:
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Cost of Delivering
Intravenous Opioid Analgesia in Emergency Departments in the
United States
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Authors:
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Pamela P. Palmer, MD
PhD, Brenda Lemus, MD, and Karen DiDonato, MSN, RN of AcelRx
Pharmaceuticals; and John House, MS of Premier, Inc.
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ECEM is the annual meeting of the European Society for Emergency
Medicine, which represents 33 European national emergency medicine
societies. The Society strives to advance research, education,
practice and standards of the specialty of emergency medicine
throughout Europe. More
information on the Society may be found at www.eusem.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). 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.