Advisory Committee Meeting Scheduled for March 29, 2016
SAN DIEGO--(BUSINESS WIRE)--Jan. 29, 2016--
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 (CNS)
disorders, today announced that the Psychopharmacologic Drugs Advisory
Committee of the U.S. Food and Drug Administration (FDA) will review
data included in ACADIA’s New Drug Application (NDA) for NUPLAZID™
(pimavanserin) for the treatment of psychosis associated with
Parkinson’s disease. The Advisory Committee Meeting is scheduled for
March 29, 2016.
“Parkinson’s disease psychosis is a debilitating condition for which
there are no FDA-approved treatment options available to patients,” said
Steve Davis, ACADIA’s President and Chief Executive Officer. “We look
forward to discussing our data from the NUPLAZID clinical program with
the members of the Committee.”
The Prescription Drug User Fee Act (PDUFA) action date for completion of
FDA review of the NUPLAZID NDA is May 1, 2016. The FDA has granted the
NUPLAZID NDA Priority Review status and designated NUPLAZID for the
treatment of psychosis associated with Parkinson’s disease as a
Breakthrough Therapy.
About The Psychopharmacologic Drugs Advisory Committee
The Committee is an independent panel of experts that reviews and
evaluates data regarding the safety and effectiveness of marketed and
investigational human drug products for use in the practice of
psychiatry and related fields and makes appropriate recommendations to
the FDA.
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 in Parkinson’s disease psychosis.
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 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.
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 (NDA) 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. The FDA has classified the NUPLAZID NDA as
having Priority Review status. 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
subscribe to receive e-mail alerts.
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 potential for NUPLAZID
(pimavanserin) to be the first drug approved in the United States for
Parkinson’s disease psychosis (PDP) and the potential timing of such
approval, if approved at all, by the FDA; the timing or outcome of any
discussion with the FDA or an advisory committee; and the benefits to be
derived from ACADIA’s product candidates, including pimavanserin. 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 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 future 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.
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Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Senior
Director of Investor Relations
(858) 558-2871