REDWOOD CITY, Calif.,
Oct. 12, 2018 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (AcelRx) (Nasdaq: ACRX), a
specialty pharmaceutical company focused on innovative therapies
for use in medically supervised settings, announced today that the
Anesthetic and Analgesic Drug Products Advisory Committee of the
U.S. Food and Drug Administration (FDA) 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. Developed to address challenges with existing
treatment options and to provide an easy-to-administer dosage form
for rapid relief as early as 15 minutes, DSUVIA is a 30 mcg
sufentanil tablet in a pre-filled applicator for sublingual
administration by a healthcare professional.
"We are pleased with the Advisory Committee's recommendation to
approve DSUVIA as a treatment in medically supervised settings for
adults experiencing moderate-to-severe acute pain," said Dr.
Pamela Palmer, Co-Founder and Chief
Medical Officer of AcelRx. "We look forward to continued
collaboration with the FDA on the application as we believe DSUVIA
represents an important non-invasive acute pain management option
with potential to significantly improve the current standard of
care."
The company presented DSUVIA efficacy and safety data from two
randomized, placebo-controlled studies with a total of 261 patients
and two open-label, single-arm studies with a total of 216
patients. In these clinical trials, DSUVIA was shown to be
well-tolerated and demonstrated efficacy across a range of patient
ages and BMIs as a non-invasive analgesic for the management of
moderate-to-severe acute pain.
The Anesthetic and Analgesic Drug Products Advisory Committee is
convened upon the request of the FDA to review and evaluate safety
and efficacy data of marketed and investigational human drug
products for use in anesthesiology and surgery, and makes
appropriate recommendations to the Commissioner of Food and Drugs.
While the FDA is not bound by the committee's recommendation, it
does take its advice into consideration. The Prescription Drug User
Fee Act (PDUFA) date for DSUVIA is November
3, 2018.
"The availability of a single-dose, non-invasive opioid, like
DSUVIA, could significantly improve my ability to effectively,
efficiently and safely alleviate acute pain experienced by my
patients," said David Leiman, M.D.,
Clinical Assistant Professor of Surgery, University of Texas at Houston, and Director, HD
Research Corp. "It is my hope that the FDA consider the
recommendation of the Advisory Committee and the current need for
additional non-invasive opioid analgesic options on behalf of
patients and healthcare providers in medically supervised
settings."
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.
Forward-Looking Statements
This press release
contains forward-looking statements, including, without limitation,
statements related to the safety, efficacy and tolerance of DSUVIA
and the potential and timing for it to be approved by the FDA, as
well as the potential for DSUVIA to potentially significantly
improve the current standard of care. These forward-looking
statements are based on AcelRx's current expectations and involve
significant risks and uncertainties. AcelRx's actual results and
timing of events could differ materially from those anticipated in
such forward-looking statements as a result of these risks and
uncertainties, including, without limitation: risks related to the
possibility that the data supporting AcelRx's DSUVIA NDA
resubmission may be disputed or interpreted differently by the FDA
such that it results in further required action by the Company or
ultimately does not support approval; any delays or the inability
to obtain and maintain regulatory approval of DSUVIA in
the United States, 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 9, 2018 and Quarterly Report on Form 10-Q
filed with the SEC on August 2, 2018.
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,
except as required by law.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/fda-advisory-committee-recommends-approval-of-dsuvia-for-the-treatment-of-moderate-to-severe-acute-pain-300730372.html
SOURCE AcelRx Pharmaceuticals, Inc.