REDWOOD CITY, Calif.,
Aug. 29, 2016 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) today announced
that the Company and its investigators will be presenting results
from the Phase 3 SAP302 study of ARX-04 (sufentanil sublingual
tablet, 30 mcg) in 76 patients who were treated for
moderate-to-severe acute pain in the emergency department. An oral
presentation reviewing these results, including the types of
injuries that were sustained by patients in the study, will be made
at the International Society for Burn Injuries (ISBI), which is
taking place August 29 – September 1 in Miami,
Florida.
As previously reported, adult patients treated with ARX-04 in
this study experienced a mean pain intensity difference of 2.9 from
a baseline of 8.1 on a validated 0 – 10 numeric rating scale at 60
minutes, meeting the study's primary objective. Injuries sustained
by patients in SAP302 included fractures, sprains/strains,
lacerations and burns, among others. Study participants
tolerated ARX-04 well, with nausea (9%), somnolence (5%) and
vomiting (4%) comprising the most commonly reported adverse
events.
The study additionally concluded that ARX-04 had no overall
impact on cognitive function.
Details on the presentation time are as follows:
Date:
|
Monday, August 29,
2016 at 1:30pm (local time)
|
|
|
Title:
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Efficacy and Safety
of Sublingual Sufentanil 30mcg for the Management of Acute
Traumatic Pain in the Emergency
Department
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|
|
Authors:
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Karen DiDonato, MSN,
RN and Pamela Palmer, MD, PhD of AcelRx Pharmaceuticals, 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 Zubaid Rafique, MD of Baylor College of
Medicine in Houston, TX
|
The International Society for Burn Injuries' first international
congress took place in 1960. In 1965, delegates of the second
congress moved to create a permanent organization with the goal of
reducing the incidence of burns, as well as improving patient care,
especially in developing countries. For more information on the
2016 Congress, please visit http://isbi2016.com.
About ARX-04
ARX-04 is a non-invasive investigational
product candidate consisting of a 30 mcg sufentanil tablet
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
moderate-to-severe acute pain in the hospital, and post-operative
patients following short-stay surgery, who do not require more
long-term patient-controlled analgesia (PCA).
The ARX-04 Phase 3 clinical program is comprised of three
studies in patients with moderate-to-severe acute pain: SAP301, a
double-blind, placebo-controlled trial in ambulatory abdominal
surgery patients; SAP302, an open-label trial in adult emergency
room patients; and SAP303, an open-label trial in postoperative
patients. Results of SAP301, which were presented in 2015 at the
American Society of Anesthesiologists annual meeting, may be viewed
on the AcelRx website.
ARX-04 is funded in part by the Clinical and Rehabilitative
Medicine Research Program (CRMRP) of the U.S. Army Medical Research
and Materiel Command (USAMRMC) under contract No.
W81XWH-15-C-0046.
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.