REDWOOD CITY, Calif.,
Oct 26, 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 pain, today announced that it will release Third Quarter
financial results after market close on Thursday, Oct 29th, 2015. AcelRx management will
host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on Oct 29th, 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 pain. The company's
late-stage pipeline includes ARX-04 (sufentanil sublingual tablet,
30 mcg) for the treatment of moderate-to-severe acute pain in a
medically supervised setting; and Zalviso™ (sufentanil sublingual
tablet system) for the management of moderate-to-severe acute pain
in adult patients in the hospital setting.
ARX-04 delivers 30 mcg sufentanil, a high therapeutic index
opioid, sublingually through a disposable, pre-filled, single-dose
applicator. AcelRx has reported positive results from the pivotal
Phase 3 SAP301 ambulatory surgery study, and has advanced ARX-04
into a study (SAP302) in emergency room patients. Zalviso delivers
15 mcg sufentanil sublingually through a non-invasive delivery
route via a pre-programmed, patient-controlled analgesia device.
Zalviso is approved in the EU and is in late-stage development in
the U.S. AcelRx submitted a New Drug Application (NDA) for Zalviso
and received a Complete Response Letter (CRL) from the FDA on
July 25, 2014. The FDA subsequently
requested an additional clinical study to evaluate the
effectiveness of product changes made in response to the CRL, and
the Company is working with the FDA regarding the resubmission of
the Zalviso NDA and initiation of a clinical study to support
resubmission.
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 development of AcelRx's product
candidates, including the process and timing of anticipated future
development of Zalviso and ARX-04; anticipated results and timing
of the completion of the SAP302 study for ARX-04; AcelRx's plans to
seek a pathway forward towards gaining approval of Zalviso in the
U.S.; and anticipated resubmission of the Zalviso NDA to the FDA,
including the scope and timing of resubmission. These
forward-looking statements are based on AcelRx's current
expectations and inherently involve significant risks and
uncertainties. AcelRx's 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:
any delays or inability to obtain and maintain regulatory approval
of its product candidates, including Zalviso and ARX-04; its
ability to successfully complete the additional clinical study
requested by the FDA to support resubmission of the Zalviso NDA;
its ability to timely resubmit the Zalviso NDA to the FDA and to
receive regulatory approval for Zalviso; the fact that the FDA may
dispute or interpret differently positive clinical results obtained
to date from the pivotal Phase 3 SAP301 ambulatory surgery study of
ARX-04; its ability to complete Phase 3 clinical development of
ARX-04; the success, cost and timing of all product development
activities and clinical trials, including the SAP302 ARX-04 trial;
and other risks detailed in the "Risk Factors" and elsewhere in
AcelRx's U.S. Securities and Exchange Commission filings and
reports, including its Quarterly Report on Form 10-Q filed with the
SEC on August 4, 2015. AcelRx
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.