REDWOOD CITY, Calif.,
April 28, 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 First Quarter
financial results after market close on Monday, May 2nd, 2016. AcelRx
management will host an investment-community conference call at
4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) on May 2nd, 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 advanced ARX-04
into studies in emergency room patients (SAP302) and post-operative
patients 40 years and older (SAP303). 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 once production and testing of the commercial supplies are
complete, and clinical sites are ready, in order to support its NDA
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, ARX-04 (sufentanil sublingual tablet, 30 mcg) and
Zalviso™ (sufentanil sublingual tablet system), including the Phase
3 SAP302 and SAP303 studies for ARX-04; AcelRx's pathway forward
towards gaining approval of Zalviso in the U.S.; the anticipated
timing, design and results of IAP312 clinical trial for Zalviso;
anticipated resubmission of the Zalviso New Drug Application, or
NDA, to the U.S. Food and Drug Administration, or 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 limitations, risks related to
AcelRx Pharmaceuticals' ability to complete Phase 3 clinical
development of ARX-04; 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; AcelRx's ability to receive regulatory approval
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 additional clinical trial for Zalviso, IAP312, and
the Phase 3 ARX-04 SAP302 and SAP303 trials; 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 accuracy of
AcelRx's estimates regarding expenses, capital requirements and the
need for financing; and other risks detailed in the "Risk Factors"
and elsewhere in AcelRx's U.S. Securities and Exchange Commission
filings and reports, including its Annual Report on Form 10-K filed
with the SEC on March 7, 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.