FDA approves Acadia's Nuplazid

FDA approved Nuplazid pimavanserin from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) to treat hallucinations and delusions associated with psychosis in Parkinson's disease patients. It is the first approved drug in the indication. Acadia plans to launch Nuplazid in June; the company declined to disclose its price.

Last month, FDA's Psychopharmacologic Drugs Advisory Committee voted that Nuplazid's benefits outweighed its risks to treat Parkinson's disease psychosis (PDP). The small molecule serotonin (5-HT2A) receptor inverse agonist has breakthrough therapy designation to treat PDP (see BioCentury Extra, March 29). ...