REDWOOD CITY, Calif.,
Dec. 6, 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, held an Analyst & Investor Event on December 1, 2016 during which members of AcelRx
management and key opinion leaders reviewed market expectations and
commercial plans for ARX-04 (sufentanil sublingual tablet, 30 mcg)
as well as the current landscape for opioid treatment in the
emergency medicine setting. During this event, AcelRx provided an
updated U.S. commercial peak sales expectation for ARX-04 of
$1.1 billion. A replay of the event
is available on the AcelRx website along with a copy of the AcelRx
slide presentation.
Presentation Highlights
- Nathaniel Katz, MD; CEO of
Analgesic Solutions, Adjunct Assistant Professor of Anesthesia
at Tufts University School of Medicine
- Provided insights into the regulatory view of opioid
approvals
- David Leiman, MD; President of
AIPM of Houston and Director of HD Research Corp
- Reviewed results of the ARX-04 clinical program: two pivotal,
randomized, placebo-controlled studies, SAP202 and SAP301
(bunionectomy and outpatient abdominal surgery); and, two
open-label Phase 3 studies, SAP302 and SAP303 (emergency
department and ambulatory surgery)
- Gina Ford; AcelRx Vice President, Commercial Strategy
- Explained the basis of AcelRx's expectations for the emergency
department market opportunity, in terms of patient numbers and
unmet need
- Provided guidance on AcelRx's anticipated pilot launch program
Emergency Department Panel
- John Holcomb, MD; Retired COL,
US Army, Division of Acute Care Surgery, Chief Center for
Translational Injury Research, University of
Texas Health Science Center, Houston, TX
- David Leiman, MD; President of
AIPM of Houston and Director of HD Research
Corp
- James Miner, MD; Chief of
Emergency Medicine, Hennepin County Medical
Center, Minneapolis, MN
- Michael Ritter, MD Emergency
Medicine Physician, St. Joseph Health Mission Hospital,
Mission Viejo, CA
- Offered informed views of the functions of an emergency
department, and the decisions that physicians and nurses must make
in order to prioritize patient care and outflow
- Discussed relative importance of speed and cost considerations
when selecting pain medications and route of administration
"The event provided an opportunity for AcelRx and several key
opinion leaders to share their outlook for ARX-04," commented
Howie Rosen, chief executive officer
of AcelRx. "The underlying theme of overcrowding in emergency rooms
combined with a non-invasive sublingual approach to the treatment
of moderate-to-severe acute pain resonates with practicing
physicians. We look forward to the submission of the NDA later this
month and in working with the FDA on its review of ARX-04."
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.
AcelRx expects to submit a New Drug Application for ARX-04 with
the U.S. Food and Drug Administration in December 2016 using the 505(b)(2) pathway. Under
these guidelines, AcelRx expects its application to be subject to a
ten-month review period.
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 and market size 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; actual market size for
AcelRx products; 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.