REDWOOD CITY, Calif.,
July 24, 2015 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx)
announced today that the Committee for Medicinal Products for Human
Use (CHMP) of the European Medicines Agency (EMA), has adopted a
positive opinion for Zalviso™ (sufentanil sublingual tablets). The
opinion, while not binding, recommends marketing authorization for
Zalviso for the management of acute moderate-to-severe
post-operative pain in adult patients. Zalviso is an
investigational drug-device combination product designed to deliver
a sublingual formulation of sufentanil 15 mcg via a proprietary
pre-programmed, non-invasive, patient-controlled device. Grunenthal
Group, AcelRx's licensee in Europe, submitted the Marketing Authorization
Application (MAA) under the centralized procedure in July of
2014.
"We believe that Zalviso represents a significant advancement in
the management of acute pain, including the moderate-to-severe
acute pain experienced by patients recovering from surgery. With
this positive opinion from CHMP, Grunenthal and AcelRx are one step
closer to bringing a non-invasive, self-dosing, pain management
system to the estimated 15.7 million Europeans who undergo
surgeries associated with moderate-to-severe post-operative pain
every year," stated Howie Rosen
interim chief executive officer of AcelRx Pharmaceuticals. "We
appreciate the collaborative approach of the CHMP and look forward
to continued collaboration with EMA to complete the regulatory
process."
The positive opinion by the CHMP will next be reviewed by the
European Commission for central marketing authorization in the
European Union (EU), which has the authority to approve medicines
for the 28 member countries of the EU which will also be valid in
Norway, Iceland and Liechtenstein. If approved, Grunenthal expects
to launch Zalviso beginning in the first half of 2016. In addition,
AcelRx would be eligible to receive a $15
million milestone payment from Grunenthal upon approval.
AcelRx had previously received CE Mark approval of the Zalviso
device and ISO certification of its quality management system
issued by the British Standards Institution, or BSI, a Notified
Body. Under the terms of the collaboration, Grunenthal is
responsible for all commercial activities for Zalviso, including
obtaining and maintaining pharmaceutical product regulatory
approval in the Grunenthal territory. AcelRx will be
responsible for maintaining device regulatory approval in the
Grunenthal territory and manufacturing and supply of Zalviso to
Grunenthal for commercial sales and clinical trials.
About Zalviso™
Zalviso is an innovative pre-programmed, non-invasive, handheld
system that allows hospital patients with acute moderate-to-severe
post-operative pain to self-dose with sufentanil sublingual
tablets, 15 mcg, to manage their pain. The system is designed to
help address certain problems associated with post-operative
analgesia, such as the side effects and delayed analgesic effect of
morphine, the invasive intravenous (IV) route of delivery of
current systems for patient-controlled analgesia (PCA) and the
complexity of infusion pumps used for IV PCA delivery. Grunenthal
holds the rights for Zalviso in Europe and Australia while AcelRx retains all rights in
North America, Asia, Latin
America and Middle
East/Africa.
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 acute pain. AcelRx's
product candidate, Zalviso, is designed for the management of
moderate-to-severe acute pain in adult patients in the hospital
setting by utilizing a high therapeutic index opioid, through a
non-invasive delivery route via a pre-programmed,
patient-controlled analgesia device. AcelRx has submitted a New
Drug Application (NDA) to the U.S. Food and Drug Administration
(FDA) seeking approval for Zalviso in the treatment of
moderate-to-severe acute pain in adult patients in the hospital
setting and on July 25, 2014,
received a Complete Response Letter (CRL) from the FDA. In
March 2015, AcelRx received
correspondence from the FDA stating that in addition to the bench
testing and two Human Factors studies AcelRx had completed in
response to the issues identified in the CRL, an additional
clinical trial is needed to assess the risk of inadvertent
dispensing and overall risk of dispensing failures. AcelRx
submitted a formal meeting request to the FDA and this request was
denied. AcelRx is currently evaluating its next steps to seek a
pathway forward towards gaining approval of Zalviso in the U.S.,
including potential additional clinical studies, additional Human
Factors studies, or the formal dispute resolution process provided
for by the FDA. In March 2015, AcelRx
initiated SAP301, a pivotal Phase 3 study for ARX-04 (sufentanil
sublingual tablet, 30 mcg), a product candidate for the treatment
of moderate-to-severe acute pain in a medically supervised setting.
AcelRx expects top-line data from this study in the fourth quarter
of 2015. The Company has two additional pain treatment product
candidates, ARX-02 and ARX-03, which have completed Phase 2
clinical development. 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, including Zalviso and ARX-04; statements related
to the therapeutic and commercial potential of Zalviso; the size of
the European market; potential approval and timing of commercial
launch of Zalviso in Europe;
potential milestone payments under the Grunenthal agreement;
AcelRx's plans to seek a pathway forward towards gaining approval
of Zalviso in the U.S., including potential additional clinical
studies, additional Human Factors studies, additional data
analyses, or the dispute resolution processes provided for by the
FDA; and the anticipated timing of the Phase 3 ARX-04, SAP-301
trial's top line results.
These forward-looking statements are based on AcelRx
Pharmaceuticals' current expectations and inherently involve
significant risks and uncertainties. AcelRx Pharmaceuticals' actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these
risks and uncertainties, which include, without limitation, risks
related to: any delays or inability to obtain and maintain
regulatory approval of its product candidates, including Zalviso,
in the United States and
Europe, and ARX-04; inability to
successfully manufacture Zalviso to meet the requirements of
Grunenthal and potential delays in the timing of the European
launch; the market potential for its product candidates, including
Zalviso, in the United States and
Europe, and ARX-04; its ability to
obtain sufficient financing to receive regulatory approval for and
commercialize Zalviso in the United
States, and complete Phase 3 clinical development of ARX-04;
AcelRx Pharmaceuticals' ability to finalize the pathway towards
timely resubmission of the Zalviso NDA to the FDA, including its
ability to use the dispute resolution process provided for by the
FDA; potential additional clinical trials, Human Factors studies,
and/or additional data analyses necessary in order to resubmit the
Zalviso NDA; the ability to maintain compliance with contractual
compliance matters and requirements; and other risks detailed in
the "Risk Factors" and elsewhere in AcelRx Pharmaceuticals' U.S.
Securities and Exchange Commission filings and reports, including
its Quarterly Report on Form 10-Q filed with the SEC on
May 5, 2015. AcelRx Pharmaceuticals
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.