ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Par...
January 29 2016 - 4:05PM
Business Wire
Advisory Committee Meeting Scheduled for
March 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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version on businesswire.com: http://www.businesswire.com/news/home/20160129005921/en/
ACADIA Pharmaceuticals Inc.Lisa Barthelemy, Senior Director of
Investor Relations(858) 558-2871
Acadia Pharmaceuticals (NASDAQ:ACAD)
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