REDWOOD CITY, Calif.,
May 24, 2018 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx or the
Company), a specialty pharmaceutical company focused on innovative
therapies for use in medically supervised settings, today announced
the acceptance of its New Drug Application (NDA) resubmission for
DSUVIA™ by the U.S. Food and Drug Administration (FDA). The FDA
considers the DSUVIA NDA resubmission a complete class 2 response
to their October 2017 action
letter. Therefore, the FDA has assigned a PDUFA (Prescription
Drug User Fee Act) goal date of November 3,
2018.
"The acceptance of the DSUVIA NDA resubmission is yet another
important milestone achieved by the Company this year," stated
Vince Angotti, Chief Executive
Officer of AcelRx. "We are one step closer to potentially
delivering a new, non-invasive treatment option for the management
of moderate-to-severe acute pain for adult patients in medically
supervised settings. We believe DSUVIA, if approved, also has
the opportunity to help U.S. hospitals manage through the
intravenous opioid shortage1 they are currently
experiencing in their facilities," continued Angotti.
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. In
Europe, the Committee for
Medicinal Products for Human Use (CHMP) of the European Medicines
Agency (EMA) has adopted a positive opinion, recommending approval
of DZUVEO. A decision by the European Commission on whether
to grant the marketing authorization is expected in the third
quarter of 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.
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 process and timing of the FDA review of
the DSUVIA™ NDA resubmission, the timing and potential
for DSUVIA's approval by the FDA, the potential for DSUVIA to help
U.S. hospitals manage through any intravenous opioid shortage, the
timing of the final decision and potential approval by the European
Commission regarding DZUVEO™. 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, DZUVEO in
Europe and ZALVISO® 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 Form 10-Q filed with the SEC on
May 10, 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.
1
https://www.ashp.org/Drug-Shortages/Shortage-Resources/Injectable-Opioid-Shortages-FAQ
View original content with
multimedia:http://www.prnewswire.com/news-releases/acelrx-announces-fda-acceptance-of-nda-for-dsuvia-300654151.html
SOURCE AcelRx Pharmaceuticals, Inc.