REDWOOD CITY, Calif.,
Nov. 9, 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, reported the publication of a
manuscript analyzing sufentanil sublingual tablet 30 mcg for
moderate-to-severe acute pain in the emergency department (ED) in
the peer-reviewed journal, The American Journal of Emergency
Medicine. This manuscript reports on the results of an
open-label, multicenter feasibility study which included
opiate-naïve patients who presented to the ED with
moderate-to-severe pain due to trauma or injury. Conclusions of
this study indicated that sufentanil sublingual tablet 30 mcg
demonstrated clinically meaningful management of moderate-to-severe
acute pain in an ED setting.
"Despite pain being the most common reason that patients present
to the ED, there are several limitations with the current treatment
options available," commented Dr. James
Miner, Chief of Emergency Medicine at the Hennepin County
Medical Center. "The use of sufentanil sublingual tablets is
particularly promising as it could lead to more efficient acute
pain treatment, thereby potentially reducing the length of stay,
which benefits both the patient and the ED."
Details on the publications:
Miner J, Rafique Z,
Minkowitz H, DiDonato K, Palmer P. Sufentanil sublingual tablet
30 mcg for moderate-to-severe acute pain in the emergency
department. The American Journal of Emergency Medicine.
Nov 2017 [Epub ahead of print].
About the Journal:
The American Journal of
Emergency Medicine (AJEM) is a key source for information on
emergency medical care. The journal covers all activities concerned
with emergency medicine and contains information to help increase
the ability to understand, recognize and treat emergency
conditions. Issues contain clinical articles, case reports, review
articles, editorials, international notes and book reviews.
About DSUVIA™ (Sufentanil Sublingual Tablet, 30
mcg)
DSUVIA™ (sufentanil sublingual tablet, SST, 30
microgram), known as ARX-04 outside the
United States, is designed to reduce moderate-to-severe
acute pain and dosing errors associated with IV administration via
its non-invasive single-dose applicator (SDA) in medically
supervised settings. Sufentanil is an opioid analgesic currently
marketed for intravenous (IV) and epidural anesthesia and
analgesia. The sufentanil pharmacokinetic profile when delivered
sublingually potentially avoids the high peak plasma levels and
short duration of action observed with IV administration. In the
EU, the European Medicines Agency (EMA) has notified the company
that the ARX-04 Marketing Authorization Application (MAA) is under
scientific review.
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 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. AcelRx's
proprietary, non-invasive sublingual formulation technology
delivers sufentanil with consistent pharmacokinetic profiles. The
company has two product candidates including 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, and ZALVISO® (sufentanil sublingual tablet
system, SST system, 15 microgram) being developed as an
innovatively designed patient-controlled analgesia (PCA) system for
reduction of moderate-to-severe acute pain in medically supervised
settings.
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; evaluation of the CRL and AcelRx's
plans for resubmission of the NDA for DSUVIA with the FDA. 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 EMA review of the ARX-04 MAA, and the possibility
that EMA may dispute or interpret differently clinical results
obtained from the ARX-04 Phase 2 and 3 studies; the possibility
that the FDA may dispute or interpret differently the results of
the ZALVISO development program, 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, including adverse events; 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 Quarterly Report on Form 10-Q filed with the
SEC on August 2, 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.