AcelRx Announces Achievement of the Primary End-Point in Phase 3 Comparative Study Involving the Sufentanil NanoTab PCA System

 AcelRx Announces Achievement of the Primary End-Point in Phase 3 Comparative
    Study Involving the Sufentanil NanoTab PCA System and Plans to Hold a
       Conference Call and Webcast Tomorrow to Discuss Top-Line Results

PR Newswire

REDWOOD CITY, Calif., Nov. 14, 2012

REDWOOD CITY, Calif., Nov. 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, announced today it had met the primary endpoint
in the Phase 3 non-inferiority study of the sublingual Sufentanil NanoTab PCA
System vs. IV PCA with morphine. The top-line data is expected to be released
prior to market opening on November 15, 2012, and following such release
AcelRx management will host an investment-community conference call at 8:00
a.m. Eastern Time (5:00 a.m. Pacific Time) to discuss the Phase 3 top-line
results.

The conference call and webcast will be held tomorrow, Thursday, November 15,
2012 at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to discuss the Phase 3
top-line results. To listen to the conference call, dial in approximately ten
minutes before the scheduled call to (800) 860-2442 for domestic callers,
(866) 605-3852 for Canadian callers, or (412) 858-4600 for international
callers. Those interested in listening to the conference call live via the
Internet may do so by visiting the Investor Relations section of the company's
website at www.acelrx.com.

A webcast replay will be available on the AcelRx website for 90 days following
the call by visiting the Investor Relations section of the company's website
at www.acelrx.com.

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, is currently in Phase 3 clinical
development and is designed to solve problems associated with post-operative
intravenous patient-controlled analgesia, including side effects of morphine,
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 that 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
Quarterly Report on Form 10-Q for the three months ended September 30, 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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