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
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.