ACADIA Pharmaceuticals Stock Trading Halted Today
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.
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.
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