SAN DIEGO--(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.
