REDWOOD CITY, Calif.,
Dec. 13, 2016 /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, announced that it has submitted a
New Drug Application (NDA) under section 505(b)(2) with the U.S.
Food and Drug Administration (FDA) for ARX-04 (sufentanil
sublingual tablet, 30 mcg) for the treatment of patients
experiencing moderate-to-severe acute pain in a medically
supervised setting.
The NDA contains results of the entire ARX-04 clinical program,
including data from four clinical trials in which ARX-04 was
assessed as a treatment for moderate-to-severe acute pain in
postoperative and emergency department patients. In each of these
clinical studies, patients treated with ARX-04 demonstrated
improvements in pain intensity as early as 15-to-30 minutes after
the start of dosing. Adverse events reported in the studies were
typical of opioid therapy, with the most common being nausea,
headache, vomiting and dizziness. For more details on these trials,
please visit the ARX-04 webpage on the AcelRx website.
"During my career before AcelRx, I saw first-hand the challenges
of treating pain with IV opioids; and through our market research,
it's clear that my experiences were not isolated," explained Dr.
Pamela Palmer, co-founder and chief
medical officer at AcelRx. "Even today, needs exist for
non-invasive, cost-effective pain management in the emergency room,
ambulatory surgical center, pre-hospital care, battlefield, and
other diverse medical settings. We believe that ARX-04, with its
sublingual delivery, could offer physicians and nurses a valuable
treatment option in the treatment of moderate-to-severe acute
pain."
Howie Rosen, AcelRx's chief executive officer, added, "The
submission of the ARX-04 NDA is a significant corporate milestone
for AcelRx. We are in the process of completing our
commercialization plans so that we will be ready for an initial
pilot launch in 2017, should ARX-04 be approved by the FDA. We also
are using the NDA to prepare a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) with a target
submission date in the first half of 2017 and are continuing to
talk with potential European partners for ARX-04."
Clinical and Rehabilitative Medicine Research Program
(CRMRP)
ARX-04 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 505(b)(2) Designation
Under the FDA's 505(b)(2)
regulatory pathway, FDA may consider data not developed by the
applicant when reviewing an NDA. It also allows the potential for
fewer pivotal Phase 3 studies and/or the enrollment of a smaller
number of patients than is typical. These allowances may reduce the
length and cost of a drug's regulatory path. In addition, the drug,
once approved by the FDA, is eligible for three years of market
exclusivity.
About ARX-04
ARX-04 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.
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
ARX-04 (sufentanil sublingual tablet, 30mcg) with a proposed
indication for the treatment of moderate-to-severe acute pain in
medically supervised settings, was recently submitted to the FDA
for review.
The Company's other late stage product, 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
as well as Norway, Iceland, and Liechtenstein 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, and Australia, while AcelRx retains all other
world-wide rights.
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,
ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso®
(sufentanil sublingual tablet system), including U.S. Food and Drug
Administration, or FDA, review of the New Drug Application, or NDA,
for ARX-04; the ARX-04 clinical trial results; AcelRx's pathway
forward towards gaining approval of Zalviso in the U.S.; and the
therapeutic and commercial potential of AcelRx's product
candidates, including potential market opportunities and market
size for 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' ARX-04 development program; the uncertain clinical
development process; the success, cost and timing of all
development activities and clinical trials; actual market size for
AcelRx products; 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 2,
2016. 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.