REDWOOD CITY, Calif.,
Aug 1, 2016 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced
that the Company and its investigators will be presenting top-line
results from the initial cohort of 40 patients in single-arm,
open-label Phase 3 SAP302 study, which assessed ARX-04
(sufentanil sublingual tablet, 30 mcg) as a treatment for
moderate-to-severe acute pain in adults who presented to the
emergency department with trauma or injury. These data will be
presented at the 7th World Congress of Mountain & Wilderness
Medicine, which is taking place July 30 -
August 4, 2016 at the Telluride Conference Center in
Telluride, Colorado. Complete
results from the SAP302 study will be presented at an upcoming
medical meeting.
The AcelRx poster will be presented at the Congress by JohnRey
Hassan, BSN, RN, a clinical nurse with the NorthBay Medical Center
Emergency Department and a flight nurse with REACH Air Medical
Services, an emergency service that provides air medical transports
for critically ill and injured patients aboard medically equipped
helicopters and airplanes. In addition, Mr. Hassan has worked as a
paramedic for the National Parks Service at Yosemite &
Yellowstone National Parks.
"As an emergency medicine nurse with career experience in the
emergency department and pre-hospital services, both in urban and
wilderness settings, JohnRey has unique insights into the
challenges of providing analgesia for patients suffering with
moderate-to-severe acute pain. This makes him an ideal presenter
for these results at a conference dedicated to the treatment and
rescue of injured climbers and other outdoor enthusiasts," added
Dr. Pamela Palmer, co-founder and chief medical officer of AcelRx
Pharmaceuticals.
Details on the presentation time are as follows:
Date:
|
Tuesday, August
2nd, 11:30am -12:10pm (local time)
|
Location:
|
Telluride Conference
Center, Mountain Village East
|
Title:
|
Phase 3 Efficacy and
Safety Results of Sufentanil Sublingual 30 mcg Tablet for
Management of Acute Traumatic Pain in Emergency Medicine
|
Authors:
|
JohnRey Hassan, BSN,
RN of NorthBay Medical Center, Fairfield, CA; James Miner, MD
of the Hennepin County Medical Center in Minneapolis, MN; Harold
Minkowitz, MD of the Memorial Hermann Memorial City Medical Center
in Houston, TX; and AcelRx Pharmaceuticals' Karen DiDonato, MSN, RN
and Pamela P. Palmer, MD, PhD
|
The World Congress of the Wilderness Medical Society attracts
those working in wilderness medicine and providing care in
challenging areas and extreme environments around the world. Topics
such as improvised rescue techniques and disaster medicine will be
presented by world experts in altitude medicine, wilderness
medicine, mountain rescue and global/environmental medicine. For
more information, please visit the congress website at
www.wms.org/conferences/telluride.
About ARX-04
ARX-04 is a non-invasive investigational
product candidate consisting of 30 mcg sufentanil tablets delivered
sublingually via a disposable, pre-filled, single-dose applicator
(SDA). AcelRx is developing ARX‑04 for the management of
moderate-to-severe acute pain in a variety of medically supervised
settings, including the emergency room, outpatient or ambulatory
surgery, non-surgical patients experiencing pain in the hospital,
and post-operative patients following short-stay surgery, who do
not require more long-term patient-controlled analgesia (PCA).
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
enrollment of 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 and the timing of such
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 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; 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.