FDA committee advances drug for psychosis associated with Parkinson's disease

Nuplazid, a drug indicated for the treatment of psychosis associated with Parkinson's disease, has been granted priority review status, according to a press release issued by Acadia Pharmaceuticals.

The FDA's Psychopharmacologic Advisory Committee voted 12 to 2 on Tuesday that the benefits of Nuplazid (pimavanserin) outweighed the risks of treatment. The committee also designated Nuplazid as a breakthrough therapy.

“We are very encouraged by the Committee’s positive vote today and look forward to working with the FDA as it completes its review of Nuplazid,” Steve Davis, Acadia’s president and CEO, said in the press release. “If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease.”

The biopharmaceutical company noted that Parkinson's disease psychosis occurs in approximately 40% of patients with the disease and commonly consists of delusions and visual hallucinations.

According to Acadia, Nuplazid demonstrated a significant reduction in psychosis compared with a placebo, did not worsen parkinsonism, and improved nighttime sleep, daytime wakefulness and caregiver burden in a phase 3 trial published in The Lancet.

The FDA is expected to complete its review of Nuplazid's New Drug Application by May 1.