REDWOOD CITY, Calif.,
Nov. 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, reported the publication of a manuscript analyzing sufentanil
sublingual tablet 30 mcg for postoperative pain in the
peer-reviewed journal, Pain Medicine. This manuscript
reports on the results of a multicenter, open-label, single-arm
study that evaluated moderate-to-severe acute postoperative pain in
an older patient population, many with comorbidities, in nine
hospitals across the United
States. Conclusions of the study highlighted that sufentanil
sublingual tablet 30 mcg was effective and well-tolerated for the
management of moderate-to-severe acute pain following a variety of
surgical procedures, including knee replacement, open-abdominal
surgery and bunionectomy.
"Postoperative pain often remains clinically undermanaged and
may lead to suboptimal outcomes for the patients," commented Dr.
Jacob Hutchins, Assistant Professor
in the Department of Anesthesiology at the University of Minnesota. "This study suggests that
sublingual sufentanil could provide a non-invasive alternative to
intravenous opioids for postoperative acute pain management across
multiple surgery types and patient populations."
Details on the publications:
Hutchins J, Leiman D,
Minkowitz H, Jove M, DiDonato K, Palmer P. An Open-Label Study of
Sufentanil Sublingual Tablet 30 mcg in Patients with Postoperative
Pain. Pain Medicine. 2017 Nov [Epub ahead of print].
About the Journal:
Pain Medicine is a
multi-disciplinary journal dedicated to pain clinicians, educators
and researchers with an interest in pain from various medical
specialties such as pain medicine, anesthesiology, family practice,
internal medicine, neurology, neurological surgery, orthopedic
spine surgery, psychiatry, and rehabilitation medicine as well as
related health disciplines such as psychology, neuroscience,
nursing, nurse practitioner, physical therapy, and integrative
health. This scholarly, indexed publication reflects the rapid
growth in pain science and practice as well as the field's need for
policy, ethical, and forensic commentary on pain and its
management. Readers benefit from both cutting-edge original
clinical and translational research and scientific reviews.
About DSUVIA™ (Sufentanil Sublingual
Tablet)
DSUVIA™ (sufentanil sublingual tablet, SST, 30
microgram), known as DZUVEO (formerly ARX-04) outside the United States, is designed to reduce
moderate-to-severe acute pain and address 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 DZUVEO 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 DZUVEO 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 DZUVEO
outside the United States, and
ZALVISO® (sufentanil sublingual tablet system), including
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 DZUVEO development programs, including
the EMA review of the DZUVEO MAA, and the possibility that EMA may
dispute or interpret differently clinical results obtained from the
DZUVEO 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 and DSUVIA
NDAs to the FDA; any delays or inability to obtain and maintain
regulatory approval of its product candidates, including DSUVIA in
the United States, DZUVEO 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 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 November 9, 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.