REDWOOD CITY, Calif.,
Dec. 2, 2014 /PRNewswire/
-- AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), a specialty
pharmaceutical company focused on the development and
commercialization of innovative therapies for the treatment of
acute and breakthrough pain today announced that it has received CE
Mark approval (Conformite Europeenne) for the Zalviso device.
Zalviso is a drug-device combination product utilizing the opioid
agonist sufentanil formulated in a proprietary sublingual tablet
formulation and delivered through a pre-programmed, non-invasive
proprietary delivery device. AcelRx has partnered with the
Grunenthal Group to commercialize Zalviso in the European Union and
Australia. AcelRx had previously
announced that in July 2014,
Grunenthal had submitted a Marketing Authorization Application
(MAA) to the European Medicines Authority for Zalviso for the
management of moderate to severe acute pain in adult patients in a
medically supervised environment. Obtaining the CE Mark is an
important step in the potential approval of the Zalviso MAA.
"The CE Mark approval is an essential regulatory milestone
for commercialization and further approval of the Zalviso MAA in
Europe," said Richard King, president and CEO of AcelRx. "We
are pleased to have received the CE Mark as it shows that AcelRx
has the capability to manufacture and develop a device that meets
commercial regulatory requirements."
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 and breakthrough pain. AcelRx's
lead product candidate, Zalviso, is designed to improve 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 announced positive
results from each of the three completed Phase 3 clinical trials
for Zalviso, and has submitted an NDA to the FDA seeking approval
for Zalviso in the treatment of moderate-to-severe acute pain in
adult patients in the hospital setting and on July 25th, received a Complete Response Letter
from the FDA. AcelRx plans to initiate a Phase 3 clinical
trial for ARX-04, a product candidate for the treatment of
moderate-to-severe acute pain in a medically supervised setting.
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 company's Zalviso NDA and the Complete
Response Letter, or CRL, the recent meeting held with the FDA to
discuss the CRL, our plans to address the issues raised in the CRL,
our anticipated resubmission of the Zalviso NDA to the FDA,
including the scope of the resubmission and the timing of the
resubmission and FDA review time, timing and potential approval of
the MAA for Zalviso in Europe,
planned initiation of the Phase 3 clinical trial for ARX-04, and
the therapeutic and commercial potential of AcelRx Pharmaceuticals'
product candidates, including Zalviso. 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:
AcelRx Pharmaceuticals' ability to receive regulatory approval for
Zalviso; any delays or inability to obtain and maintain regulatory
approval of its product candidates, including Zalviso, in
the United States and Europe; AcelRx's ability to build an effective
commercial organization; its ability to obtain sufficient financing
to commercialize Zalviso and proceed with clinical development of
ARX-04; the success, cost and timing of all product development
activities and clinical trials, including the planned Phase 3
ARX-04 trial; the market potential for its product candidates; 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 November 10, 2014. 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.