FDA reviewers question Nuplazid benefit

In documents released ahead of Tuesday's meeting of FDA's Psychopharmacologic Drugs Advisory Committee, agency reviewers questioned whether Nuplazid pimavanserin from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) showed clinically meaningful benefits in patients with Parkinson's disease psychosis (PDP).

"While the applicant will present evidence that the treatment effect represents a clinically meaningful change, the Division's medical officer will present his interpretation of the same data and reach a different conclusion," wrote Director of the Division of Psychiatry Products Mitchell Mathis in a memorandum to PDAC. ...