REDWOOD CITY, Calif.,
July 6, 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 Chief Executive Officer,
Howard Rosen will be presenting at
the Cantor Fitzgerald 2nd Annual Healthcare Conference. Details of
the conference are as follows:
Cantor Fitzgerald 2nd Annual Healthcare
Conference
Date: Tuesday, July
12
Location: Le Parker Meridien, New
York
Presentation Time: 2pm ET, 11am
PT
The presentation will be webcast live and can be accessed
through the Investors page at www.acelrx.com. For those not
available to listen to the live broadcast, a replay will be
archived for 90 days and available through the Investors page on
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 inSAP-302) 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.