Acadia Pharma (ACAD) NUPLAZID NDA Accepted for Review; 05/01/16 PDUFA Date Set

November 2, 2015 8:12 AM EST

Acadia Pharma (NASDAQ: ACAD) announced that the New Drug Application (NDA) for NUPLAZID™ (pimavanserin) has been accepted for review by the U.S. Food and Drug Administration (FDA) and the agency has granted it Priority Review. ACADIA is seeking FDA approval of NUPLAZID for the treatment of psychosis associated with Parkinson’s disease. The FDA granted NUPLAZID Breakthrough Therapy designation for this indication in 2014.

The FDA grants Priority Review to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. Priority Review accelerates the review timeline from 10 months to six months from the date of acceptance of filing. The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of May 1, 2016.

“The FDA Priority Review designation underscores the potential for NUPLAZID to provide an important treatment to patients with Parkinson’s disease psychosis, a condition for which there is no FDA-approved therapy,” said Steve Davis, ACADIA’s President and Chief Executive Officer. “We look forward to working with the FDA during the review.”

NUPLAZID is a new class of non-dopaminergic antipsychotic that acts as an SSIA (selective serotonin inverse agonist), preferentially targeting 5-HT2A receptors. Through this novel mechanism, NUPLAZID has demonstrated significant efficacy in 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.

ACADIA’s NDA submission is based on data from a comprehensive development program assessing the safety and efficacy of NUPLAZID for Parkinson’s disease psychosis. The NDA includes data from the pivotal Phase III -020 Study, in which NUPLAZID showed statistical improvement on all primary and secondary efficacy endpoints with no worsening of motor function. Detailed results of the -020 Study were published in The Lancet.



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