REDWOOD CITY, Calif.,
April 6, 2017 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
moderate-to-severe acute pain, announced that efficacy and
integrated safety results from the DSUVIA™ (formerly
ARX-04) clinical program would be presented as an e-poster during
the Annual Regional Anesthesiology and Acute Pain Medicine Meeting.
The e-poster will be presented during a moderated session by
Harold Minkowitz, MD, an
anesthesiologist at Memorial Hermann Memorial City Medical Center
in Houston. This marks the first
comprehensive presentation of the integrated efficacy and safety
results from the DSUVIA clinical program as submitted to the US
Food and Drug Administration in the company's New Drug
Application.
In total, 480 patients were enrolled across all four DSUVIA
late-phase studies. Two randomized, placebo-controlled studies,
SAP202 and SAP301, enrolled patients who had undergone bunionectomy
and abdominal surgeries; and two open-label, single-arm trials
assessed DSUVIA in the emergency department (SAP302) and in older,
post-operative patients, many with comorbidities (SAP303). The
presentation concludes that DSUVIA, while still under FDA review,
may have benefit as a non-invasive analgesic modality in medically
supervised settings requiring short-term treatment of acute
moderate-to-severe pain. In the emergency department study, DSUVIA
resulted in a 3-point reduction in pain intensity within 60 minutes
of administration, with clinically meaningful relief within 15-30
minutes. In general, adverse events were mild-to-moderate in
severity with the most commonly reported (≥3%) nausea, headache and
vomiting, which occurred in 28.9%, 8.0% and 6.3% of DSUVIA
patients, and 21.6%, 13.5% and 1.4% of placebo patients,
respectively. No statistical separation was observed between the
active and placebo-controlled groups.
The Annual Regional Anesthesiology and Acute Pain Medicine
Meeting is hosted by the American Society of Regional Anesthesia
and Pain Medicine (ASRA) and is taking place April 6-8, 2017 in San
Francisco, CA. For more information on the society, please
visit www.asra.com.
Details on the presentations are as follows:
Title:
|
Comprehensive
Efficacy and Integrated Safety Results from the Late-Phase Clinical
Program of the Sublingual Sufentanil Tablet 30 mcg (Poster ID
3876)
|
Authors:
|
Harold Minkowitz, MD
of the Memorial Hermann Memorial City Medical Center in Houston,
TX; Timothy Melson, MD of the Helen Keller Hospital in Sheffield,
AL; David Leiman, MD of the Hermann Drive Surgical Hospital in
Houston, TX; Karen DiDonato, MSN, RN and Pamela Palmer, MD, PhD of
AcelRx Pharmaceuticals
|
Time/Place:
|
Thursday, April 6,
2017 from 3:45-5:15 pm PT in Salon 5
|
|
|
Clinical and Rehabilitative Medicine Research Program
(CRMRP)
DSUVIA 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. The CRMRP was established in 2008 to foster
research and technology advances for regeneration, restoration, and
rehabilitation of traumatic injuries.
In accordance with USAMRMC guidelines, in the conduct of
clinical research, AcelRx has adhered to the policies regarding the
protection of human subjects as prescribed by Code of Federal
Regulations (CFR) Title 45, Volume 1, Part 46; Title 32, Chapter 1,
Part 219; and Title 21, Chapter 1, Part 50 (Protection of Human
Subjects).
About DSUVIA (Formerly ARX-04)
DSUVIA is a
non-invasive investigational product candidate consisting of 30 mcg
sufentanil tablets delivered sublingually by a healthcare
professional using a disposable, pre-filled, single-dose applicator
(SDA). Sufentanil is a synthetic opioid analgesic with a high
therapeutic index and no known active metabolites.
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, has
been accepted for filing by the FDA in the United States. 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 follow on product candidate, ZALVISO® (sufentanil
sublingual tablet system), designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting, is currently enrolling patients in a Phase 3 clinical
trial, IAP312. 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 U.S.
Grunenthal Group holds the rights for ZALVISO in Europe, where a commercial launch has
begun.
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 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 U.S.,
including successful completion of the IAP312 clinical study for
ZALVISO; and the therapeutic and commercial potential of AcelRx's
product candidates. 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
and the EMA review of the ARX-04 MAA, including 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 ZALVISO development program, including successful completion of
IAP312 and 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; the success and timing of all development
activities and clinical trials; 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-K filed with the SEC on March 3, 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.