REDWOOD CITY, Calif.,
Jan. 21, 2016 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced
that a presentation will be made at the annual European Congress of
Ambulatory Surgery to be held January
28th and 29th, 2016 at the Disneyland Hotel New York
Convention Centre in Paris,
France. This bilingual congress (simultaneous translation
will be provided) is co-organized by AFCA (French Association for
Ambulatory Surgery) and the IAAS (International Association for
Ambulatory Surgery) and will bring together over 800 ambulatory
surgery stakeholders from Europe,
Asia and North America.
The presentation marks the first time comprehensive results from
the completed Phase 3 study (SAP301) using sublingual sufentanil 30
mcg tablets for the management of moderate-to-severe acute pain in
outpatient abdominal surgery patients will be presented to the
European academic and scientific community.
Details on the presentation time are as follows:
Session: FPS 3 - PARALLEL SESSIONS – Free AFCA-IAAS Papers
Room: ROOM 3
Date: 28 January 2016 from 14:00 to
14:45 (local time)
Title: Efficacy and Safety of Sublingual Sufentanil for the
Management of Acute Pain Following Ambulatory
Surgery
Authors: Harold Minkowitz,
MD; Neil Singla, MD; David Leiman, MD; Timothy Melson, MD; Karen DiDonato, MSN, RN and Pamela P.
Palmer, MD, PhD
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™ 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 a study (SAP302) in emergency room patients. In addition,
AcelRx intends to initiate SAP303 in the first quarter of 2016,
with a focus on enrolling patients greater than 40 years of age,
allowing for administration of ARX-04 for up to 12 hours. 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 the first quarter of 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, including Zalviso and ARX-04; timing for initiation of
IAP312 for Zalviso and SAP303 studies for ARX-04; AcelRx's plans to
seek a pathway forward towards gaining approval of Zalviso in
the United States; and anticipated
resubmission of the Zalviso NDA to the FDA. 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; its ability to successfully design and complete
the additional clinical study requested by the FDA to support
resubmission of the Zalviso NDA; its ability to timely resubmit the
Zalviso NDA to the FDA and to receive regulatory approval for
Zalviso; the fact that the FDA may dispute or interpret differently
positive clinical results obtained to date from the pivotal Phase 3
ambulatory surgery study of ARX-04 (SAP301); 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 SAP302 and SAP303 ARX-04 trials and the
IAP312 Zalviso 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 November 3,
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.