REDWOOD CITY, Calif.,
Oct. 3, 2012 /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 a decision by the
European Medicines Agency, or EMA, to permit registration of the
Sufentanil NanoTab PCA System (ARX-01) via the centralized
procedure under Article 3(2) (b) of Regulation EC 726/2004.
This procedure will allow AcelRx to submit a single Marketing
Authorization Application, or MAA, to the EMA for approval to
market ARX-01 in all 27 European Union, or EU, member states, as
well as in the 4 European Free Trade Association, or EFTA,
countries, through a single evaluation that will be carried out
through the Committee for Medicinal Products for Human Use.
The 31 EU / EFTA countries represent a population of over 500
million people, with more than 20 million patients undergoing
surgery each year resulting in moderate to severe pain in the days
after surgery.
ARX-01 is a novel, non-invasive, sublingual patient-controlled
analgesia (PCA) system currently in three Phase 3 clinical trials
for the treatment of post-operative pain. Top line results
from these trials are expected to be available later this year and
during the first quarter of 2013. Assuming positive results
in this Phase 3 program, AcelRx plans to submit a New Drug
Application, or NDA, to the United States Food and Drug
Administration in the third quarter of 2013. Based on
informal scientific advice meetings held with two national European
regulatory authorities, AcelRx believes that the data compiled for
the NDA will also be sufficient to file an MAA in Europe.
"This decision by the EMA allows us to pursue registration of
ARX-01 through the more efficient centralized review process,
rather than separate applications for approval in each country,"
said Richard King, AcelRx's
president and CEO. "Registration via the Centralized
Procedure is typically reserved for products with significant
therapeutic, scientific or technical innovation, and reflects the
genuinely novel approach to post-operative pain management that is
inherent in the design of our non-invasive, preprogrammed
Sufentanil NanoTab PCA System."
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, the ARX-01 Sufentanil
NanoTab PCA System, is currently in Phase 3 clinical development
and is designed to solve problems associated with post-operative
intravenous patient-controlled analgesia, including side effects of
morphine, invasive IV route of delivery and the inherent potential
for programming and delivery errors associated with the complexity
of infusion pumps. AcelRx has two additional product candidates
that have completed Phase 2 clinical development: ARX-02 for the
treatment of cancer breakthrough pain and ARX-03 for mild sedation,
anxiety reduction and pain relief for patients undergoing painful
procedures in a physician's office. AcelRx plans to initiate
a Phase 2 study for a fourth product candidate, ARX-04, a
sufentanil formulation for the treatment of moderate-to-severe
acute pain, funded through a grant from USAMRMC. 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 an MAA submission to the EMA, the planned or
anticipated future clinical development of AcelRx Pharmaceuticals'
product candidates, including the anticipated timing for clinical
trials, the timing of the top line data from all three Phase 3
clinical trials, the timing of submission of an NDA to the FDA and
therapeutic and commercial potential of AcelRx Pharmaceuticals'
product candidates. 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:
the success, cost and timing of AcelRx Pharmaceuticals' product
development activities and clinical trials; the uncertain clinical
development process, including the risk that planned clinical
trials may not begin on time, have an effective design, enroll a
sufficient number of patients, or be initiated or completed on
schedule, if at all; any delays or inability to obtain regulatory
approval of its product candidates in the
United States and Europe;
its ability to obtain adequate clinical supplies of the drug and
device components of its product candidates; its ability to attract
funding partners or collaborators with development, regulatory and
commercialization expertise; its ability to obtain sufficient
financing to complete development and registration of its product
candidates in the United States
and Europe; its ability to obtain
and maintain regulatory approvals of its product candidates in
the United States and Europe; the market potential for its product
candidates; the accuracy of AcelRx Pharmaceuticals' estimates
regarding expenses, capital requirements and needs for financing;
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
for the three months ended June 30,
2012. 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.
SOURCE AcelRx Pharmaceuticals, Inc.