FDA Advisory Committee to Review NUPLAZID™ (Pimavanserin)
New Drug Application for the Treatment of Parkinson’s
Disease Psychosis
SAN DIEGO—(BUSINESS WIRE)—Mar. 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 NASDAQ has halted trading of the
company’s common stock.
The U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs
Advisory Committee (PDAC) is meeting today to review NUPLAZID™
(pimavanserin) for the treatment of patients with
psychosis associated with Parkinson’s disease.
The Advisory Committee meeting is scheduled for 8:00 a.m. ET. The
briefing materials can be found on the FDA website at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/ucm475314.htm.
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 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 Parkinson’s disease psychosis 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) 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 progress and timing of ACADIA’s
drug discovery and development programs, including clinical trials, the
benefits to be derived from ACADIA’s product candidates, in each case
including NUPLAZID (pimavanserin), and the potential for NUPLAZID to be
the first drug approved in the United States for Parkinson’s disease
psychosis, if approved at all. 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 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160329005493/en/
Source: ACADIA Pharmaceuticals Inc.
Investor Contact:
ACADIA Pharmaceuticals Inc.
Lisa
Barthelemy
(858) 558-2871
or
Media
Contact:
Taft and Partners
Ted Deutsch
(609)
578-8765
[email protected]