REDWOOD CITY, Calif.,
July 26, 2016
/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 Second
Quarter financial results after market close on Thursday, July 28th, 2016. AcelRx management will
host an investment-community conference call at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on July 28th, 2016 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) designed for the treatment of moderate-to-severe acute pain
in a medically-supervised setting; and Zalviso® (sufentanil
sublingual tablet system) designed 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 completed
enrollment in SAP302 in emergency room patients and SAP303 in
post-operative patients. The NDA for ARX-04 is expected to be filed
by the end of 2016. Zalviso delivers 15 mcg sufentanil
sublingually through a non-invasive delivery route via a
pre-programmed, patient-controlled analgesia device. In response to
the New Drug Application (NDA) AcelRx submitted to the U.S. Food
and Drug Administration (FDA) seeking approval for Zalviso, AcelRx
received a Complete Response Letter (CRL) on July 25, 2014. The FDA has requested an
additional clinical study (IAP312), which AcelRx is planning to
initiate in 2016, to support resubmission of the NDA.
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, ARX-04 (sufentanil sublingual tablet, 30 mcg) and
Zalviso® (sufentanil sublingual tablet system), including the
timing and results of ARX-04 clinical trials, anticipated timing of
NDA submission for ARX-4, planned initiation of the IAP312 clinical
trial for Zalviso; anticipated resubmission of the Zalviso NDA to
the U.S. Food and Drug Administration, or FDA; the timing of
completion of ARX -04 clinical program and submission of
ARX-04 NDA to the FDA; and the therapeutic and commercial potential
of AcelRx's product candidates, including ARX-04 and Zalviso. These
forward-looking statements are based on AcelRx Pharmaceuticals'
current expectations and inherently involve significant risks and
uncertainties. AcelRx Pharmaceuticals' actual results and timing of
events could differ materially from those anticipated in such
forward-looking statements, and as a result of these risks and
uncertainties, which include, without limitation, risks related to
AcelRx Pharmaceuticals' ability to complete Phase 3 clinical
development of ARX-04 and support ARX-04 development under the
contract with the Department of Defense and NDA submission;
AcelRx's ability to successfully execute the pathway towards a
resubmission of the Zalviso NDA to the FDA, including the
initiation and completion of the IAP312 clinical study for Zalviso;
any delays or inability to obtain and maintain regulatory approval
of its product candidates, including ARX-04 in the United States and Europe, and Zalviso in the United States; the uncertain clinical
development process, including adverse events; the risk that
planned clinical trials may not begin on time, have an effective
clinical design, enroll a sufficient number of patients, or be
initiated or completed on schedule, if at all; the success, cost
and timing of all development activities and clinical trials,
including the Phase 3 ARX-04 SAP302 and SAP303 trials, and the
additional clinical trial for Zalviso, IAP312; the fact that the
FDA may dispute or interpret differently clinical results obtained
to date from the Phase 3 SAP301 study of ARX-04; the market
potential for AcelRx's product candidates; 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 May 2, 2016. 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.