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AcelRx to Present Top-Line Data from Phase 3 Study of Sufentanil NanoTab® PCA System vs. IV PCA Morphine at the 66th Annual

AcelRx to Present Top-Line Data from Phase 3 Study of Sufentanil NanoTab® PCA
    System vs. IV PCA Morphine at the 66th Annual PostGraduate Assembly in
                     Anesthesiology held in New York City

- First medical meeting presentation of top-line Phase 3 data demonstrating
NanoTab System met both non-inferiority and superiority comparisons to IV PCA
with morphine in open-label study -

PR Newswire

REDWOOD CITY, Calif., Dec. 14, 2012

REDWOOD CITY, Calif., Dec. 14, 2012 /PRNewswire/ --AcelRx Pharmaceuticals,
Inc. (Nasdaq: ACRX), a specialty pharmaceutical company focused on the
development and commercialization of innovative therapies for the treatment of
acute and breakthrough pain, today announced that top-line data from its
previously announced open-label, active-comparator study of its lead product
candidate, the Sufentanil NanoTab PCA System, will be featured in poster
presentations to be held at the 66^th annual New York State Society of
Anesthesiologists PostGraduate Assembly meeting in New York City to be held
December 14-18, 2012. The poster is authored by Dr. Timothy Melson of Helen
Keller Hospital, Sheffield, AL, Dr. Alparslan Turan of The Cleveland Clinic,
Cleveland, OH, and Dr. Pamela Palmer of University of California, San
Francisco, and Chief Medical Officer of AcelRx Pharmaceuticals and will be
presented on Sunday, December 16, 2012 from 11:00 AM to 1:00 PM at the New
York Marriott Marquis.

Top-line results of the Phase 3 clinical trial demonstrate that the Sufentanil
NanoTab PCA System was non-inferior (p<0.001) to intravenous (IV)
patient-controlled analgesia (PCA) with morphine for the primary endpoint of
Patient Global Assessment (PGA) of method of pain control over the 48-hour
study period as determined by the combined percentage of patients with PGA
ratings of "good" or "excellent" (78.5% vs. 66.1% respectively). The
assessment of non-inferiority is based on a lower limit of -15% for the 95%
confidence interval (CI) around the difference between these percentages.
Because the 95% CI was +3.2% to +21.6% for the 48-hour PGA, a statistical
analysis for superiority could be performed, which demonstrated that for this
study, the NanoTab System was statistically superior to IV PCA morphine for
the PGA endpoint (p=0.009). This statistically superior PGA was also seen at
the 24 hour and 72 hour time points. Additionally, the percentage of patients
rating the NanoTab System as "Excellent" was higher than those rating IV PCA
morphine as excellent (42.9% vs. 30.6%, p=0.016). Similar percentages of
NanoTab System-treated and IV PCA morphine-treated patients dropped out of the
study prematurely due to lack of efficacy (7.3% vs. 8.3% respectively) or due
to an adverse event (7.9% vs. 11.1% respectively).

Nurses setting up the different treatments for use and managing patients in
the study reported greater Overall Satisfaction (3.93 vs. 3.32 out of 5,
p<0.001) and Overall Ease of Care (4.26 vs. 3.82, p=0.018) with the Sufentanil
NanoTab PCA System compared to IV PCA morphine. Likewise, patients in the
study reported they had greater Overall Satisfaction (4.15 vs. 3.83 out of 5,
p=0.003) and greater Overall Ease of Care (4.45 vs. 4.07, p<0.001) with the
NanoTab System compared to IV PCA morphine.

"We are delighted to have the opportunityto present this important data at
the prestigious PostGraduate Assembly meeting," commented Pamela Palmer MD,
PhD, Chief Medical Officer and AcelRx co-founder. "These first data from our
Phase 3 program for the Sufentanil NanoTab PCA System demonstrate superiority
over IV PCA morphine for both primary and secondary endpoints. We look
forward to the completion of our two remaining Phase 3 studies, which we
expect to deliver in the first quarter of 2013," added Dr. Palmer.

About Post-Operative Pain
Acute pain management in the hospital, in particular post-operative analgesia,
remains a challenge for healthcare providers with up to 75% of patients
reporting inadequate pain relief following surgery. Inadequate treatment of
post-surgical pain can lead to decreased mobility, which increases the risks
for serious medical complications, including deep vein thrombosis and partial
lung collapse, potentially resulting in extended hospital stays. More than 30
million surgical procedures per year result in moderate to severe pain in the
US and EU, with an additional 27 million procedures in countries with moderate
to high per capita healthcare expenditures. The US, 5 main EU countries and
Japan represented $5.1 billion of acute pain treatment product sales in 2008.
Currently patients experiencing post-operative pain in the hospital may have
IV PCA treatment, typically utilizing morphine or hydromorphone. However,
there are deficiencies associated with the current use of IV PCA that can
negatively impact patient safety, well-being and recovery. These include
drug-related side effects associated with morphine or hydromorphone,
complications associated with IV delivery, and medication delivery errors
typically associated with misprogramming of the complex IV PCA pumps.

About ARX-01, the Sufentanil NanoTab PCA System
ARX-01 is an investigational pre-programmed, non-invasive, handheld system
that allows postoperative patients to self-dose with sublingual Sufentanil
NanoTabs to manage their postoperative pain. The ARX-01 System is designed to
address the limitations of IV PCA by offering:

  oA high therapeutic index opioid: ARX-01 uses the high therapeutic index
    opioid sufentanil; it offers post-operative pain patients the potential
    for effective patient-controlled analgesia with a low incidence of
    drug-related side effects.
  oA non-invasive route of delivery: The sublingual route of delivery used in
    ARX-01 provides rapid onset of analgesia, therefore eliminating the risk
    of IV-related analgesic gaps and IV complications, such as
    catheter-related infections. In addition, because patients are not
    tethered to IV tubing and a pump for pain relief, ARX-01 allows for ease
    of patient mobility.
  oA simple, pre-programmed PCA solution: ARX-01 is a pre-programmed PCA
    System designed to eliminate the risk of pump programming errors.

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 and breakthrough pain. AcelRx's lead product candidate, the
ARX-01 Sufentanil NanoTab PCA System, which is currently in Phase 3 clinical
development, is designed to solve the problems associated with post-operative
intravenous patient-controlled analgesia which has been shown to cause harm to
patients following surgery because of the side effects of morphine, the
invasive IV 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 mild sedation,
anxiety reduction and pain relief for patients undergoing painful procedures
in a physician's office. AcelRx has initiated a Phase 2 study for a fourth
product candidate, ARX-04, a sufentanil formulation for the treatment of
moderate-to-severe acute pain, funded through a grant from the U.S. Army
Medical Research and Materiel Command. 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
clinical development of AcelRx Pharmaceuticals' product candidates, including
the release ARX-01 top-line clinical trial data, the release and anticipated
timing of additional ARX-01 clinical trial data, the potential filing of an
NDA for the ARX-01 and the timing thereof, therapeutic and commercial
potential of ARX-01 and the anticipated timing and therapeutic and commercial
potential of other AcelRx Pharmaceuticals' product candidates. These
forward-looking statements are based on AcelRx Pharmaceuticals' 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 ability of AcelRx Pharmaceuticals to successfully
complete the clinical trials for ARX-01, that fact that subsequent analyses of
the full data set may lead to different (including less favorable)
interpretations of the results than the analyses conducted to date or may
identify important implications of the study that are not reflected in these
statements, or be subject to differing interpretations by the regulatory
agencies; the success, cost and timing of all product development activities
and clinical trials; the uncertain clinical development process, including the
risk that clinical trials, have an effective design, enroll a sufficient
number of patients, or be completed on schedule, if at all; any delays or
inability to obtain regulatory approval of its product candidates in the
United States and Europe; its ability to obtain adequate clinical supplies of
the drug and device components of its product candidates; its ability to
attract funding partners or collaborators with development, regulatory and
commercialization expertise; its ability to obtain sufficient financing to
complete development and registration of its product candidates in the United
States and Europe; its ability to obtain and maintain regulatory approvals of
its product candidates in the United States and Europe; the market potential
for its product candidates; the accuracy of AcelRx Pharmaceuticals' estimates
regarding expenses, capital requirements and needs for financing; and other
risks detailed in the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals'
U.S. Securities and Exchange Commission filings and reports, including its
Current Report on Form 8-K filed with the SEC on December 7, 2012. 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.

Website: http://www.acelrx.com
Contact: Jim Welch, Chief Financial Officer, +1-650-216-3511,
jwelch@acelrx.com
 
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