REDWOOD CITY, Calif.,
Sept. 14, 2016 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. (NASDAQ: ACRX) a specialty pharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of acute pain, will announce
the results of its multicenter, open-label Phase 3 clinical study
of ARX-04, known as SAP303. The study was conducted in patients 40
years and older who have moderate-to-severe acute pain following a
surgical procedure. Patients were administered one dose of ARX-04
(sufentanil sublingual tablet, 30 mcg) every 60 minutes, as needed
for pain management, for up to 12 hours.
Conference Call
AcelRx will conduct a conference call and webcast tomorrow
morning, September 15, at
9:00 a.m. Eastern time (6:00 a.m. Pacific time) to discuss this update
and the trial results. To listen to the conference call, dial in
approximately ten minutes before the scheduled call to 877-407-9129
for domestic and Canadian callers, or 201-493-6753 for
international callers. Those interested in listening to the
conference call live via the Internet may do so by visiting the
Investors section of the company's website at www.acelrx.com and
selecting the Webcast link for the ARX-04 Phase 3 Trial Results
Call. A webcast replay will be available on the AcelRx website for
90 days following the call by visiting the Investors section of the
company's website at www.acelrx.com.
About ARX-04
ARX-04 is a non-invasive investigational product candidate
consisting of a 30 mcg sufentanil tablet delivered sublingually in
a controlled setting by healthcare professionals 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 is developing ARX-04 for the management of
moderate-to-severe acute pain in a variety of medically supervised
settings, including the emergency room, outpatient or ambulatory
surgery, non-surgical patients experiencing moderate-to-severe
acute pain in the hospital, and post-operative patients following
short-stay surgery, who do not require more long-term
patient-controlled analgesia (PCA).
The ARX-04 Phase 3 clinical program is comprised of three
studies in patients with moderate-to-severe acute pain: SAP301, a
double-blind, placebo-controlled trial in ambulatory abdominal
surgery patients; SAP302, an open-label trial in adult emergency
room patients; and SAP303, an open-label trial in post-operative
patients. Results of SAP301, which were presented in 2015 at the
American Society of Anesthesiologists annual meeting, and results
of SAP302, which were presented at the 2016 Military Health System
Research Symposium, may be viewed on the AcelRx website.
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.
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.
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 US. 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.; 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 to
date from the Phase 3 studies of ARX-04; 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; 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.
![AcelRx logo AcelRx logo](http://photos.prnewswire.com/prnvar/20130226/MM67303LOGO)
Logo -
http://photos.prnewswire.com/prnh/20130226/MM67303LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/acelrx-pharmaceuticals-to-announce-topline-results-in-phase-3-study-of-arx-04-in-patients-with-post-operative-moderate-to-severe-acute-pain-300327875.html
SOURCE AcelRx Pharmaceuticals, Inc.