Acadia announced that the Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) voted in favor (12–2) that the benefits of Nuplazid (primavanserin) outweighed the risks for the treatment of psychosis associated with Parkinson’s’ disease.

The New Drug Application (NDA) submission was based on data from a Phase 3 -020 Study where Nuplazid demonstrated statistical improvement on all primary and secondary endpoints without motor function worsening. If approved by the FDA, it would be the first drug for the treatment of psychosis associated with Parkinson’s disease.

RELATED: Novel SSIA Agent Granted Priority Review for Parkinson’s Disease Psychosis

Nuplazid, an oral selective serotonin inverse agonist (SSIA), preferentially targets 5-HT2A receptors that are involved in psychosis. It has been granted Priority Review status and designated as Breakthrough Therapy by the FDA.

The Prescription Drug User Fee Act (PDUFA) action date for completion of the NDA review is May 1, 2016. The FDA takes into consideration the Committee’s advice but is not bound by the recommendation.

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