REDWOOD CITY, Calif.,
May 6, 2016 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced that the
Company and its investigators will be presenting a subgroup
analysis of the Phase 3 SAP301 study results by surgery type
(abdominoplasty, hernioplasty and laparoscopic abdominal surgery).
SAP301 was a Phase 3 trial comparing ARX-04 (sufentanil sublingual
30 mcg tablet) to a placebo sublingual tablet in 163 patients with
moderate-to-severe acute pain following ambulatory abdominal
surgery. The analysis will be presented at the Society for
Ambulatory Anesthesia (SAMBA) 31st Annual Meeting, which
is being held May 5-7, 2016 in
Orlando, FL.
Details on the
presentation time are as follows:
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Date:
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Saturday, May 7, 2016
at 12:00 – 1:30pm (local time)
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Title:
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Safety and Efficacy
of Sufentanil Sublingual 30 mcg Tablets by Surgery Type for the
Treatment of Acute Pain following Outpatient Abdominal
Surgery
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Authors:
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Dr. Harold Minkowitz,
MD of the Memorial Hermann Memorial City Medical Center in Houston,
TX; Neil Singla, 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
AcelRx Pharmaceuticals' Karen DiDonato, MSN, RN and Pamela P.
Palmer, MD PhD
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SAMBA provides a venue for anesthesiologists, anesthesia
providers, practitioners, nurses and administrators who work and
specialize in ambulatory or office-based anesthesia to learn about
the latest clinical advances presented by experts in the field. For
more information on the conferences, please visit
www.sambahq.org.
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 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 a
medically supervised setting; and Zalviso™ (sufentanil sublingual
tablet system) designed for the management of moderate-to-severe
acute pain in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index
opioid, sublingually through a disposable, pre-filled, single-dose
applicator. AcelRx has reported positive results from the pivotal
Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04
into studies in emergency room patients (SAP302) and post-operative
patients 40 years and older (SAP303). Zalviso delivers 15 mcg
sufentanil sublingually through a non-invasive delivery route via a
pre-programmed, patient-controlled analgesia device. In response to
the New Drug Application (NDA) AcelRx submitted to the U.S. Food
and Drug Administration (FDA) seeking approval for Zalviso, AcelRx
received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an
additional clinical study (IAP312), which AcelRx is planning to
initiate once supplies are available, have been tested with
acceptable results, and clinical sites are ready, in order to
support its NDA resubmission.
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
planned initiation of the IAP312 clinical trial for Zalviso;
anticipated resubmission of the Zalviso NDA to the U.S. Food and
Drug Administration, or FDA; and the therapeutic and commercial
potential of AcelRx's product candidates, including 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' ability to complete Phase
3 clinical development of ARX-04 and support ARX-04 development
under the contract with the Department of Defense; AcelRx's ability
to successfully execute the pathway towards a resubmission of the
Zalviso NDA to the FDA, including the initiation and completion of
the IAP312 clinical study for Zalviso; 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 begin on time, have
an effective clinical design, enroll a sufficient number of
patients, or be initiated or completed on schedule, if at all; the
success, cost and timing of all development activities and clinical
trials, including the Phase 3 ARX-04 SAP302 and SAP303 trials, and
the additional clinical trial for Zalviso, IAP312; the fact that
the FDA may dispute or interpret differently clinical results
obtained to date from the Phase 3 SAP301 study of ARX-04; the
market potential for AcelRx's product candidates; and other risks
detailed in the "Risk Factors" and elsewhere in AcelRx's U.S.
Securities and Exchange Commission filings and reports, including
its Annual Report on Form 10-Q filed with the SEC on May 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.