REDWOOD CITY, Calif.,
Sept. 6, 2017 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a
specialty pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
moderate-to-severe acute pain, today announced that Vincent J. Angotti, chief executive officer,
will be presenting at the Rodman and Renshaw 19th Annual
Global Investment Conference and the Cantor Fitzgerald 2017 Global
Healthcare Conference. Details of the events are as follows:
Rodman & Renshaw 19th Annual Global Investment
Conference
Date: Monday, September
11th
Location: Lotte New York Palace Hotel, New York
Presentation Time: 11:15 am ET
(8:15 am PT)
Cantor Fitzgerald Global Healthcare Conference
Date:
Wednesday, September 27th
Location: InterContinental New York Barclay Hotel, New York
Presentation Time: 9:45 am ET
(6:45 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 moderate-to-severe acute pain. A New Drug
Application (NDA) for DSUVIA™ (sufentanil sublingual
tablet, 30 mcg), known as ARX-04 outside the United States, with a proposed indication
for the treatment of moderate-to-severe acute pain in medically
supervised settings, was accepted for filing by the United States
Food and Drug Administration (FDA) and has been given a PDUFA date
of October 12, 2017. In the EU, the
European Medicines Agency (EMA) has notified the company that the
ARX-04 (sufentanil sublingual tablet, 30 mcg) Marketing
Authorisation Application (MAA) has passed validation and that the
scientific review of the MAA is underway.
The company's product candidate, ZALVISO® (sufentanil
sublingual tablet system), is designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting. The company recently completed a Phase 3 clinical trial,
IAP312, which included input from the FDA on the study protocol.
This study was designed to evaluate the effectiveness of changes
made to the functionality and usability of the ZALVISO device, to
evaluate the incidence of inadvertent dosing, and to take into
account comments from the FDA on the study protocol. AcelRx intends
to resubmit the NDA for ZALVISO to the FDA by the end of the year.
ZALVISO delivers 15 mcg sufentanil sublingually through a
non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. ZALVISO is approved in the EU
and is investigational and in late-stage development in
the United States. Grunenthal
Group holds the rights for ZALVISO in Europe, where a commercialization across
multiple countries is underway.
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, DSUVIA™
(sufentanil sublingual tablet, 30 mcg), known as ARX-04 outside
the United States, and
ZALVISO® (sufentanil sublingual tablet system),
including U.S. Food and Drug Administration, or FDA, review of the
New Drug Application, or NDA, for DSUVIA; the potential approval of
the DSUVIA NDA by the FDA; the European Medicines Agency (EMA)
scientific review of the ARX-04 Marketing Authorisation Application
(MAA); the DSUVIA and ARX-04 clinical trial results; AcelRx's
pathway forward towards gaining approval of ZALVISO in the United States, including the planned
resubmission and timing of the ZALVISO NDA to the FDA; and the
therapeutic and commercial potential of AcelRx's product
candidates, including potential market opportunities for DSUVIA,
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' DSUVIA and ARX-04
development programs, including the FDA review of the DSUVIA NDA,
the EMA review of the ARX-04 MAA, and the possibility that the FDA
or EMA may dispute or interpret differently clinical results
obtained from the DSUVIA or ARX-04 Phase 2 and 3 studies; the
possibility that the FDA may dispute or interpret differently the
results of the ZALVISO development program, including the results
from the IAP312 clinical trial; the resubmission of the ZALVISO NDA
to the FDA; any delays or inability to obtain and maintain
regulatory approval of its product candidates, including DSUVIA in
the United States, ARX-04 in
Europe and ZALVISO in the United States; the uncertain clinical
development process, including adverse events; the success, cost
and timing of all development activities and clinical trials; 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 Quarterly
Report on Form 10-Q filed with the SEC on August 2, 2017. 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.