PDUFA Date Set for May 1, 2016
SAN DIEGO—(BUSINESS WIRE)—Nov. 2, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company
focused on the development and commercialization of innovative medicines
to address unmet medical needs in central nervous system disorders,
today announced that the New Drug Application (NDA) for NUPLAZID™ (pimavanserin)
has been accepted for review by the U.S. Food and Drug Administration
(FDA) and the agency has granted it Priority Review. ACADIA is seeking
FDA approval of NUPLAZID for the treatment of psychosis associated with
Parkinson’s disease. The FDA granted NUPLAZID Breakthrough Therapy
designation for this indication in 2014.
The FDA grants Priority Review to drugs that may offer major advances in
treatment or may provide a treatment where no adequate therapy exists.
Priority Review accelerates the review timeline from 10 months to six
months from the date of acceptance of filing. The FDA has set a target
action date under the Prescription Drug User Fee Act (PDUFA) of May 1,
2016.
“The FDA Priority Review designation underscores the potential for
NUPLAZID to provide an important treatment to patients with Parkinson’s
disease psychosis, a condition for which there is no FDA-approved
therapy,” said Steve Davis, ACADIA’s President and Chief Executive
Officer. “We look forward to working with the FDA during the review.”
NUPLAZID is a new class of non-dopaminergic antipsychotic that acts as
an SSIA (selective serotonin inverse agonist), preferentially targeting
5-HT2A receptors. Through this novel mechanism, NUPLAZID has
demonstrated significant efficacy in Parkinson’s disease psychosis.
According to the National Parkinson Foundation, about one million people
in the United States and from four to six million people worldwide
suffer from Parkinson’s disease. An estimated 40 percent of these
patients have Parkinson’s disease psychosis, which is characterized by
hallucinations and delusions, a diminished quality of life, and
significant caregiver burden.
ACADIA’s NDA submission is based on data from a comprehensive
development program assessing the safety and efficacy of NUPLAZID for
Parkinson’s disease psychosis. The NDA includes data from the pivotal
Phase III -020 Study, in which NUPLAZID showed statistical improvement
on all primary and secondary efficacy endpoints with no worsening of
motor function. Detailed results of the -020 Study were published in The
Lancet.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selective
serotonin inverse agonist preferentially targeting 5-HT2A receptors
that play an important role in psychosis. ACADIA has reported positive
Phase III trial results with NUPLAZID. The NDA for NUPLAZID for the
treatment of psychosis associated with Parkinson’s disease is currently
under Priority Review with the FDA. NUPLAZID is administered orally
once-a-day. ACADIA discovered NUPLAZID and holds worldwide rights to
this new chemical entity. The trade name NUPLAZID has been provisionally
accepted by the FDA. The safety and efficacy of NUPLAZID have not been
fully evaluated by any regulatory authority.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development and
commercialization of innovative medicines to address unmet medical needs
in central nervous system disorders. ACADIA has a pipeline of product
candidates led by NUPLAZID™ (pimavanserin), for which we have submitted
a New Drug Application in Parkinson’s disease psychosis to the FDA and
which has the potential to be the first drug approved in the United
States for this condition. Pimavanserin is also in Phase II development
for Alzheimer’s disease psychosis and has successfully completed a Phase
II trial in schizophrenia. ACADIA also has clinical-stage programs for
glaucoma and, in collaboration with Allergan, Inc., for chronic pain.
ACADIA maintains a website at www.acadia-pharm.com
to which we regularly post copies of our press releases as well as
additional information and through which interested parties can
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Forward-Looking Statements
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include but are
not limited to statements related to the timing of the potential
approval of an NDA for NUPLAZID (pimavanserin); the potential for
NUPLAZID to be the first drug approved in the United States for
Parkinson’s disease psychosis; the potential benefits to be derived from
ACADIA’s product candidates, including NUPLAZID; and the progress,
timing and results of ACADIA’s drug discovery and development programs,
either alone or with a partner, including the progress and expected
timing of clinical trials. These statements are only predictions based
on current information and expectations and involve a number of risks
and uncertainties. Actual events or results may differ materially from
those projected in any of such statements due to various factors,
including the risks and uncertainties inherent in drug discovery,
development, approval and commercialization, and in collaborations with
others, and the fact that past results of clinical trials and past
regulatory decisions may not be indicative of future trial results or
regulatory decisions, respectively. For a discussion of these and other
factors, please refer to ACADIA’s annual report on Form 10-K for the
year ended December 31, 2014 as well as ACADIA’s subsequent filings with
the Securities and Exchange Commission. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof, except as required by law.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151102005516/en/
Source: ACADIA Pharmaceuticals Inc.
Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa
Barthelemy, 858-558-2871
Director of Investor Relations
or
Media
Contact:
Chandler Chicco Agency
David Polk,
310-309-1029 or 805-428-5775