REDWOOD CITY, Calif.,
May 18, 2011 /PRNewswire/ -- AcelRx
Pharmaceuticals, Inc. announced today that the results from its
Phase 2 clinical studies related to two product candidates, ARX-01
Sufentanil NanoTab(R) PCA System, which is designed to solve the
problems associated with post-operative intravenous
patient-controlled analgesia and ARX-03 to provide mild sedation,
anxiety reduction and pain relief for patients undergoing painful
procedures in a physician's office, will be featured in poster
presentations at the upcoming American Pain Society Annual
Meeting to be held in Austin, TX,
on May 18th-21st, 2011.
Commenting on the poster presentations, Pamela Palmer, MD, PhD, AcelRx co-founder and
Chief Medical Officer said, "We are delighted that these data are
being presented at this prestigious meeting by investigators
involved in the studies. In particular, the combined data
from ARX-01 Phase 2 studies highlight advantages of our
post-operative pain management approach over existing methods that
we hope to confirm in our Phase 3 studies."
Lead investigator, Harold
Minkowitz, MD of the Memorial Hermann Memorial City Medical
Center in Houston, TX will present
analyses of the combined results from two randomized,
placebo-controlled Phase 2 studies and one Phase 2 open-label
system functionality study evaluating the safety and efficacy of
the ARX-01 sublingual Sufentanil NanoTab(R) PCA System. ARX-01 is a
non-invasive, sublingual alternative to intravenous
patient-controlled analgesia (IV PCA). The results from the 212
patients included in these three studies indicate that ARX-01 was
effective in treating both major orthopedic and major abdominal
post-operative pain with minimal adverse effects.
Also presented will be results from a randomized,
placebo-controlled Phase 2 study to evaluate the safety and
effectiveness of ARX-03, a novel sublingual combination of
sufentanil and triazolam that offers mild sedation, anxiolysis and
analgesia for patients undergoing painful office-based procedures.
Neil Singla, MD of Lotus Clinical Research in Pasadena, CA will present data from 40
patients who underwent elective low-volume liposuction.
Administration of ARX-03 produced mild sedation and
anxiolysis with rapid onset of effect, high physician and patient
evaluations of effectiveness and tolerability, and a low incidence
of side effects. Copies of these abstracts are available from
the AcelRx Pharmaceuticals web site at
www.acelrx.com/technology/publications.
About AcelRx Pharmaceuticals, Inc.
Based in Redwood City, CA,
AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX) is a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain. AcelRx's lead product candidate, the
ARX-01 Sufentanil NanoTab(R) PCA System, which has completed Phase
2 clinical development, is designed to solve the problems
associated with post-operative intravenous patient-controlled
analgesia (IV PCA) which has been shown to cause harm to patients
following surgery because of the side effects of morphine, the
invasive IV route of delivery and the inherent potential for
programming and delivery errors associated with the complexity of
infusion pumps. AcelRx has two additional product candidates which
have completed Phase 2 clinical development: ARX-02 for the
treatment of cancer breakthrough pain, and ARX-03 for providing
mild sedation, anxiety reduction and pain relief for patients
undergoing painful procedures in a physician's office.
Forward Looking Statements
This press release contains forward-looking statements,
including, but not limited to, statements related to AcelRx
Pharmaceuticals' statements related to clinical trial updates,
effectiveness and advantages of its post-operative pain management
approach and product candidate development. These
forward-looking statements are based on the company's current
expectations and inherently involve significant risks and
uncertainties. AcelRx Pharmaceuticals' actual results and the
timing of events could differ materially from those anticipated in
such forward looking statements as a result of these risks and
uncertainties, which include, without limitation, risks related to:
the success, cost and timing of AcelRx Pharmaceutical's product
development activities and clinical trials; its ability to obtain
and maintain regulatory approval of its product candidates; its
ability to obtain funding for its operations; its plans to
research, develop and commercialize its product candidates; its
ability to attract collaborators with development, regulatory and
commercialization expertise; the accuracy of AcelRx
Pharmaceutical's estimates regarding expenses, capital requirements
and needs for financing; and other risks detailed in the "Risk
Factors" and elsewhere in AcelRx Pharmaceuticals' Securities and
Exchange Commission filings and reports, including its Annual
Report on Form 10-K for the year ended December 31, 2010 and its Quarterly Report on
From 10-Q for the three months ended March
31, 2011. AcelRx Pharmaceuticals 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.
SOURCE AcelRx Pharmaceuticals, Inc.