REDWOOD CITY, Calif.,
Aug. 31, 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 Timothy E. Morris,
chief financial officer will be presenting at the BioCentury 23rd
Annual NewsMakers Conference and the Rodman & Renshaw 18th
Annual Global Investment Conference. Details of the events are as
follows:
BioCentury 23rd Annual NewsMakers
Conference
Date: Friday, September
9th
Location: Millennium Hotel New York
Presentation Time: 1:30 pm ET
(10:30 am PT)
Rodman & Renshaw 18th Annual Global Investment
Conference
Date: Tuesday, September
13th
Location: The Lotte New York Palace Hotel
Presentation Time: 10:50 am ET
(7:50 am PT)
Presentations 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 recently completed
SAP302 (study in emergency room patients) and SAP303 (study in
post-operative patients 40 years and older). 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 supply testing is complete 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 ARX-04 clinical trial
results; anticipated submission of the New Drug Application, or
NDA, for ARX-04 to the U.S. Food and Drug Administration, or FDA;
AcelRx's pathway forward towards gaining approval of Zalviso in the
U.S.; the anticipated timing, design and results of the IAP312
clinical trial for Zalviso; anticipated resubmission of the Zalviso
NDA to the FDA including the scope of the resubmission and the
timing of the resubmission, and FDA review time; and the
therapeutic and commercial potential of AcelRx's product
candidates, including potential market opportunities for 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 successfully
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; 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 studies of ARX-04 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-Q filed with the SEC on July 29, 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.