FDA Advisory Panel Backs Acadia’s Psychosis Drug

Despite limited data and only one positive Phase 3 trial, an FDA panel voted 12‒2 to recommend Acadia Pharmaceuticals’ Nuplazid for treating psychosis associated with Parkinson’s disease.

The Psychopharmacologic Drugs Advisory Committee concluded that Acadia provided substantial evidence of effectiveness. However, panelists touched on the limitations of the pivotal clinical trial, particularly questioning its 200-subject size. If approved, Nuplazid would be the first treatment for psychosis in Parkinson’s disease.

To back its application, Acadia also included the results of three other trials, none of which produced statistically positive results, according to FDA briefing documents. The agency acknowledged that it typically requires data from more than one positive trial, but it has authority to rely on a sole study.