FDA Advisory Committee Votes 12 to 2 That Benefits of ACADIA Pharmaceuticals’ NUPLAZID™ (Pimavanserin) for the Treatment ...
March 29 2016 - 5:13PM
Business Wire
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 U.S. Food
and Drug Administration (FDA) Psychopharmacologic Drugs Advisory
Committee (PDAC) voted 12 to 2 that the benefits of NUPLAZID™
(pimavanserin) for the treatment of psychosis associated with
Parkinson’s disease outweigh the risks of treatment.
The Prescription Drug User Fee Act (PDUFA) action date for
completion of FDA review of the NUPLAZID New Drug Application (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.
“We are very encouraged by the Committee’s positive vote today
and look forward to working with the FDA as it completes its review
of NUPLAZID,” said Steve Davis, ACADIA’s President and Chief
Executive Officer. “If approved by the FDA, NUPLAZID would be the
first drug indicated to treat psychosis associated with Parkinson’s
disease.”
The Advisory Committee provides the FDA with independent expert
advice and recommendations on the safety and efficacy of potential
new medicines. The FDA is not bound by the Committee's
recommendation, but takes its advice into consideration when
reviewing new drug applications.
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 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. The New Drug
Application for NUPLAZID for psychosis associated with Parkinson’s
disease is currently under review by the FDA. NUPLAZID is an oral
medicine that, if approved, would be taken once a day (34 mg).
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 (NDA) for psychosis
associated with Parkinson’s disease 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 psychosis associated with Parkinson’s
disease, if approved at all; the potential timing of such approval;
and whether the FDA will take into consideration the recommendation
of the Advisory Committee of the benefit-risk profile of NUPLAZID
when reviewing the NDA for NUPLAZID. 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, regulatory
approval and commercialization, the fact that the FDA is not bound
by the vote of the Advisory Committee, and the fact that past
results of clinical trials may not be indicative of future trial
results. 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, 2015 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/20160329006563/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy(858)
558-2871orMedia Contact:Taft and PartnersTed Deutsch(609)
578-8765ted@taftandpartners.com
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