REDWOOD CITY, Calif.,
Sept. 24, 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 the company will host an Analyst & Investor Day
on Friday, October 2 in New York from 12:00pm – 2:00pm
ET.
Members of the management team will discuss the AcelRx
late-stage product candidates, Zalviso™ and ARX-04. A comprehensive
update will also be provided on ARX-04, including recently reported
and updated clinical results, anticipated market size and
regulatory plans. Guest speakers scheduled to present at the event
include:
- Dr. Harold Minkowitz, an
anesthesiologist with the Hermann Memorial City Medical Center in
Houston, TX; and
- Dr. James Miner, the chief of
emergency medicine at Hennepin County Medical Center in
Minneapolis, MN
An update will also be provided on Zalviso, which was recently
approved for sale in the European Union.
The event 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.
For more information or to RSVP please contact Patrick Till at ptill@troutgroup.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. In the US, 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 sublingual, a high therapeutic index opioid, through a
disposable, pre-filled, single-dose applicator (SDA). AcelRx has
reported positive results from the pivotal Phase 3 SAP301
ambulatory surgery study, and will be advancing ARX-04 into a study
in emergency room patients in 2015. Zalviso delivers 15 mcg
sufentanil sublingual tablets 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, the Company received a Complete Response Letter (CRL) on
July 25, 2014. The FDA has requested
an additional clinical study prior to the resubmission of the
Zalviso NDA. Zalviso is authorized for marketing in the
European Union as well as in the European Economic Union.
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 anticipated timing of the emergency room study
for ARX-04. 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,
the market potential for its product candidates, including Zalviso
and ARX-04, in the United States and Europe; its
ability to timely resubmit Zalviso NDA to the FDA and to
receive regulatory approval for Zalviso, that fact
that 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 planned Phase 3 ARX-04 emergency room 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.