REDWOOD CITY, Calif.,
Aug. 7, 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 announced that it will release
second quarter 2014 financial results after market close on
Monday, August 11th, 2014. AcelRx
management will host an investment-community conference call at
4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on August 11th, 2014 to discuss the financial
results and provide a corporate update.
Investors who wish to participate in the conference call may do
so by dialing (877) 870-4263 for domestic callers, (855) 669-9657
for Canadian callers or (412) 317-0790 for international callers.
Those interested in listening to the conference call live via the
internet may do so by visiting the Investors page of the company's
website at www.acelrx.com and clicking on the webcast link on the
Investors home page.
A webcast replay will be available on the AcelRx website for 90
days following the call by visiting the Investor page 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, 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 and on
July 25th, received a Complete
Response Letter from the FDA. 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, by the end 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,
including, but not limited to, statements related to the Company's
Zalviso NDA and the Complete Response Letter ("CRL"), our plans to
address the issues raised in the CRL, our anticipated resubmission
of the Zalviso NDA to the FDA, including the scope of the
resubmission and the timing of the resubmission and FDA review
time, planned initiation of the Phase 3 clinical trial for ARX-04,
and the therapeutic potential of AcelRx Pharmaceuticals' product
candidates, including Zalviso. 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: AcelRx
Pharmaceuticals' ability to receive regulatory approval for
Zalviso; any delays or inability to obtain and maintain regulatory
approval of its product candidates, including Zalviso, in
the United States and Europe; AcelRx's ability to build an effective
commercial organization; its ability to obtain sufficient financing
to commercialize Zalviso and proceed with clinical development of
ARX-04; the success, cost and timing of all product development
activities and clinical trials, including the planned Phase 3
ARX-04 trial; the market potential for its product candidates; 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.