FDA Advisory Committee to Review NUPLAZID™ (Pimavanserin)New Drug Application for the Treatment of Parkinson’sDisease Psychosis
SAN DIEGO—(BUSINESS WIRE)—Mar. 29, 2016—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on the development and commercialization of innovative medicinesto address unmet medical needs in central nervous system (CNS)disorders, today announced that NASDAQ has halted trading of thecompany’s common stock.
The U.S. Food and Drug Administration (FDA) Psychopharmacologic DrugsAdvisory Committee (PDAC) is meeting today to review NUPLAZID™(pimavanserin) for the treatment of patients withpsychosis associated with Parkinson’s disease.
The Advisory Committee meeting is scheduled for 8:00 a.m. ET. Thebriefing 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 andevaluates data regarding the safety and effectiveness of marketed andinvestigational human drug products for use in the practice ofpsychiatry and related fields and makes appropriate recommendations tothe FDA.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, about one million peoplein the United States and from four to six million people worldwidesuffer from Parkinson’s disease. An estimated 40 percent of thesepatients have Parkinson’s disease psychosis, which is characterized byhallucinations and delusions, a diminished quality of life, andsignificant caregiver burden.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2Areceptors that play an important role in psychosis. The New DrugApplication for NUPLAZID for Parkinson’s disease psychosis is currentlyunder review by the FDA. NUPLAZID is an oral medicine that, if approved,would be taken once a day (34 mg). ACADIA discovered NUPLAZID and holdsworldwide rights to this new chemical entity. The trade name NUPLAZIDhas been provisionally accepted by the FDA. The safety and efficacy ofNUPLAZID have not been fully evaluated by any regulatory authority.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin central nervous system disorders. ACADIA has a pipeline of productcandidates led by NUPLAZID™ (pimavanserin), for which we have submitteda New Drug Application (NDA) in Parkinson’s disease psychosis to the FDAand which has the potential to be the first drug approved in the UnitedStates for this condition. The FDA has classified the NUPLAZID NDA ashaving Priority Review status. ACADIA maintains a website at www.acadia-pharm.comto which we regularly post copies of our press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the progress and timing of ACADIA’sdrug discovery and development programs, including clinical trials, thebenefits to be derived from ACADIA’s product candidates, in each caseincluding NUPLAZID (pimavanserin), and the potential for NUPLAZID to bethe first drug approved in the United States for Parkinson’s diseasepsychosis, if approved at all. These statements are only predictionsbased on current information and expectations and involve a number ofrisks and uncertainties. Actual events or results may differ materiallyfrom 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 pastresults of clinical trials may not be indicative of future trialresults. For a discussion of these and other factors, please refer toACADIA’s annual report on Form 10-K for the year ended December 31, 2015as well as ACADIA’s subsequent filings with the Securities and ExchangeCommission. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof. Thiscaution is made under the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995. All forward-looking statementsare qualified in their entirety by this cautionary statement and ACADIAundertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof, except asrequired by law.
Source: ACADIA Pharmaceuticals Inc.
Investor Contact:
ACADIA Pharmaceuticals Inc.
LisaBarthelemy
(858) 558-2871
or
MediaContact:
Taft and Partners
Ted Deutsch
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ted@taftandpartners.com