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ACADIA Pharmaceuticals Announces FDA Advisory Committee Meeting to Review NUPLAZID™ (Pimavanserin) for the Treatment of Parkinson’s Disease Psychosis
Advisory Committee Meeting Scheduled for March 29, 2016

SAN DIEGO--(BUSINESS WIRE)--Jan. 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 the Psychopharmacologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data included in ACADIA’s New Drug Application (NDA) for NUPLAZID™ (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease. The Advisory Committee Meeting is scheduled for March 29, 2016.

“Parkinson’s disease psychosis is a debilitating condition for which there are no FDA-approved treatment options available to patients,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We look forward to discussing our data from the NUPLAZID clinical program with the members of the Committee.”

The Prescription Drug User Fee Act (PDUFA) action date for completion of FDA review of the NUPLAZID 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.

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.
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Source: press release, 1/29/16. http://news.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&I...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Nuplazid (Pimavanserin) (ACP-103) Parkinson’s disease psychosis (PDP)NeurologyParkinson’s disease psychosis (PDP)5-HT2A receptor inverse agonist5-HT2A receptor

Mechanism of action: Nuplazid (Pimavanserin) (ACP-103), a SM-inverse agonist, demonstrates anti psychotic effects via a potent and selective 5-HT2A inverse agonist mechanism of activity.

Phase of Development: Filed

Event Type: Regulatory FDA: Advisory Committee Meeting

Dates: 2016-03-29

Results:

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FDA Advisory Committee Votes 12 to 2 That Benefits of ACADIA Pharmaceuticals’ NUPLAZID™ (Pimavanserin) for the Treatment of Psychosis Associated with Parkinson’s Disease Outweigh the Risks
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 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.
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Source: press release, 3/29/16. http://news.acadia-pharm.com/phoenix.zhtml?c=125180&p=irol-newsArticle&I...

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