REDWOOD CITY, Calif.,
April 30, 2015 /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
First Quarter financial results after market close on Monday, May 4th, 2015. AcelRx management will
host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on May 4th, 2015 to discuss the financial results
and provide a corporate update.
Investors who wish to participate in the conference call may do
so by dialing (866) 361-2335 for domestic callers, (855) 669-9657
for Canadian callers or (412) 902-4204 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 for 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 had 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 25, 2014, received a Complete Response
Letter from the FDA. AcelRx received correspondence from the FDA
stating that in addition to the bench testing and two Human Factors
studies AcelRx has performed, an additional clinical study is
needed to assess the risk of inadvertent dispensing and overall
risk of dispensing failures. AcelRx plans to meet with the FDA to
discuss and understand the need and potential objectives of an
additional clinical study for Zalviso. AcelRx has initiated 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.
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, or CRL, our
anticipated resubmission of the Zalviso NDA to the FDA, the Phase 3
clinical trial for ARX-04, and the therapeutic and commercial
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; 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 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 Annual Report on Form 10-K filed with
the SEC on March 13, 2015. 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.