REDWOOD CITY, Calif.,
Oct. 19, 2018 /PRNewswire/ -- In
response to opinions expressed following the U.S. Food and Drug
Administration (FDA) Anesthetic and Analgesic Drug Products
Advisory Committee meeting on October
12, AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX)
stands by the safety, efficacy and medical need for its
investigational therapy, DSUVIA™. Developed in collaboration with
the Department of Defense, DSUVIA potentially represents an
important non-invasive, rapidly acting alternative to IV opioids,
the current standard of care for acute pain management in medically
supervised settings.
We appreciate the thoughtful and thorough discussion among the
13 committee members, as well as the forum for public commentary.
The Committee voted 10-3 in favor of recommending the approval of
DSUVIA for the management of moderate-to-severe acute pain in
medically supervised settings for adult patients. AcelRx is
committed to continued collaboration with the FDA on the new drug
application for DSUVIA.
About DSUVIA (sufentanil sublingual tablet), 30
mcg
DSUVIA (sufentanil sublingual tablet, 30
microgram), known as DZUVEO™ outside the
United States, has a proposed
indication for the management of moderate-to-severe acute pain
in medically supervised settings, in adult patients and was
designed to eliminate dosing errors associated with IV
administration via its non-invasive single-dose applicator (SDA)
administered by health care professionals. Sufentanil is an opioid
analgesic currently marketed for intravenous (IV) and epidural
anesthesia and analgesia. The sufentanil
pharmacokinetic profile when delivered sublingually avoids the high
peak plasma levels and short duration of action observed with IV
administration. The European Medicines Agency (EMA) approved DZUVEO
for marketing in Europe in
June 2018.
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 use in medically supervised settings. 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 in Europe, 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 mcg) being developed as an innovatively
designed patient-controlled analgesia (PCA) system for reduction of
moderate-to-severe acute pain in medically supervised settings.
DZUVEO and Zalviso are both approved products in Europe.
For additional information about AcelRx's clinical programs,
please visit www.acelrx.com.
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SOURCE AcelRx Pharmaceuticals, Inc.