FDA committee will review ACADIA Pharmaceuticals’ NUPLAZID

ACADIA Pharmaceuticals announced last week that the Psychopharmacologic Drugs Advisory Committee, a committee that operates under the Food and Drug Administration (FDA), will review its New Drug Application (NDA) for NUPLAZID.

NUPLAZID was developed to treat psychosis linked to Parkinson’s disease. ACADIA specializes in medicines to meet needs that have not yet been addressed in regards to the central nervous system. The meeting to review NUPLAZID is set for March 29.

There are currently no medicines available that focus on Parkinson’s disease psychosis. If the members of the Psychopharmacologic Drugs Advisory Committee approve the application, which is based on data from clinical trials, then NUPLAZID would be the first medicine of its kind approved by the FDA.

NUPLAZID has been given a Prescription Drug User Fee Act action date for completion of the FDA review of May 1. The product’s NDA has been given Priority Review status, and its treatment of Parkinson’s disease psychosis has already been designated as a Breakthrough Therapy.