REDWOOD CITY, Calif.,
March 16, 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, will present data from the DSUVIA™
(sufentanil sublingual tablet, 30 mcg) clinical program at two
upcoming medical meetings. On March 16,
2017, during the annual meeting of the American Academy of
Pain Medicine, AcelRx will present a poster from SAP101 comparing
the pharmacokinetics of DSUVIA to that of an intravenous (IV)
infusion of Sufenta® (sufentanil citrate injection, 30 mcg). On
March 21, 2017, AcelRx will present
safety and efficacy findings from SAP302 during the International
Symposium on Intensive Care and Emergency Medicine being held in
Brussels. SAP302 was an open-label
Phase 3 trial conducted in 76 adult patients who present to the
emergency department with moderate-to-severe acute pain associated
with trauma or injury.
Details on the presentations are as follows:
Meeting:
|
American Academy of
Pain Medicine
|
Title:
|
Pharmacokinetics of a
Single Dose of Sufentanil Sublingual Tablet 30 mcg vs Intravenous
Sufenta® 30 mcg (50 mcg/mL) Infused over 1 Minute in Healthy
Volunteers
|
Authors:
|
Sandra Willsie, DO,
MA; Karen DiDonato, MSN, RN; Pamela P. Palmer, MD, PhD
|
Time/Date:
|
6:00pm on March
16th – 11:00am on March 17th
|
Meeting:
|
International
Symposium on Intensive Care and Emergency Medicine
|
Title:
|
Safety and Efficacy
of the Sufentanil Sublingual Tablet 30 mcg for Management of Acute
Traumatic Pain
|
Authors:
|
James Miner, MD;
Riccardo Leto, MD; Zubaid Rafique, MD; Francesco Della Corte,
MD
|
Time/Date:
|
6:00pm on March
21st
|
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.
DSUVIA is an investigational product candidate and is not
approved in any geography.
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. An NDA for
DSUVIA (sufentanil sublingual tablet, 30mcg) with a proposed
indication for the treatment of moderate-to-severe acute pain in
medically supervised settings, was accepted for filing by the
FDA.
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,
DSUVIATM (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 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; 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
and the possibility that the FDA may dispute or interpret
differently clinical results obtained from the DSUVIA Phase 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, cost 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.