REDWOOD CITY, Calif.,
July 24, 2014 /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 confirmed the PDUFA date for
Zalviso remains July 27,
2014.
The company recently learned that a rumor circulated online
stating the Food and Drug Administration (FDA) had approved
Zalviso. As of July 24, 2014
there has been no notification to the company from the FDA
regarding the status of the Zalviso New Drug Application
(NDA).
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, ZALVISO, is designed to improve the
management of moderate-to-severe acute pain in adult patients in
the hospital setting by utilizing a high therapeutic index opioid,
through a non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. AcelRx has announced positive
results from each of the three completed Phase 3 clinical trials
for ZALVISO, and has submitted an NDA to the FDA seeking approval
for ZALVISO in the treatment of moderate-to-severe acute pain in
adult patients in the hospital setting. AcelRx plans to
initiate a Phase 3 clinical trial for ARX-04, a product candidate
for the treatment of moderate-to-severe acute pain in a medically
supervised setting, during the second half of 2014. The company has
two additional pain treatment product candidates, ARX-02 and
ARX-03, which have completed Phase 2 clinical development.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
Forward-Looking Statements
This press release
contains forward-looking statements related to the anticipated
approval of the Company's Zalviso NDA by the FDA. 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, AcelRx Pharmaceuticals' ability to
receive regulatory approval for Zalviso; 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 filed with the SEC on
May 8, 2014. 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.
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SOURCE AcelRx Pharmaceuticals, Inc.