REDWOOD CITY, Calif.,
May 26, 2016 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced
that the Company and its investigators will be presenting Phase 3
SAP301 study results at Euroanaesthesia 2016, which is taking place
in London, UK on May 28-30, 2016. In the SAP301 study, patients
with moderate-to-severe acute pain following abdominoplasty,
hernioplasty or laparoscopic abdominal surgeries were randomized to
receive either ARX-04 (sufentanil sublingual 30 mcg tablet) or a
placebo sublingual tablet. The study met its primary endpoint with
statistically significant pain intensity differences to baseline
over the 12-hour study period (SPID12) in favor of ARX-04
(p<0.001). When analyzed by type of surgery, treatment with
ARX-04 resulted in a statistically significant benefit over placebo
in each surgery type. ARX-04 was well tolerated in the trial, with
nausea, headache and vomiting being the most common
treatment-emergent adverse events reported.
Details on the presentation time are as follows:
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Date:
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Monday, May 30, 2016
at 12:15 – 1:45pm (local time)
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Title:
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Safety and efficacy
of sufentanil sublingual 30 mcg tablets for the treatment of acute
pain following outpatient
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 AcelRx Pharmaceuticals' Karen DiDonato, MSN, RN and Pamela P.
Palmer, MD PhD
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Euroanaesthesia is Europe's
largest annual event showcasing the latest and the most relevant
information in the fields of anesthesia, perioperative medicine,
intensive care, emergency medicine and pain treatment. Upwards of
6,000 delegates from 80 countries are expected to attend. For more
information on the conferences, please visit
euroanaesthesia2016.esahq.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 ARX-04
clinical trial results; 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; the timing of
completion of ARX -04 clinical program and submission of
ARX-04 NDA to the 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 Quarterly 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.
Contacts:
Timothy E.
Morris
Chief Financial Officer
650.216.3511
tmorris@acelrx.com
Brian Korb
The Trout Group LLC
646.378.2923
bkorb@troutgroup.com
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SOURCE AcelRx Pharmaceuticals, Inc.