FDA Panel Endorses Drug that Treats Psychosis in Parkinson's Disease

An FDA panel yesterday supported the approval of a novel treatment for psychosis associated with Parkinson’s disease.

The FDA Psychopharmacologic Drugs Advisory Committee (PDAC) voted 12 to 2 that the benefits of pimavanserin (Nuplazid), manufactured by Acadia Pharmaceuticals, outweigh the risks treating psychosis in patients with Parkinson’s.

“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,” President and Chief Executive Officer of Acadia Pharmaceuticals Steve Davis said in a press release. “If approved by the FDA, Nuplazid would be the first drug indicated to treat psychosis associated with Parkinson’s disease.”

Although the FDA are not bound to the committee’s recommendation, the advice of the expert panel is heavily taken into consideration during the review of new drug applications.

Acadia seeks approval for the drug to treat hallucinations, delusions, and irrational behavior associated with the disease. The once-daily oral small molecule drug is a selective serotonin inverse agonist preferentially targeting 5-HT_2A receptors that play a key role in psychosis.

During the public hearing on Tuesday, a review was presented that evaluated patient hallucinations and other symptoms in individuals taking Nuplazid, which showed a 23% improvement compared with placebo, according to a report by the Associated Press. However, approximately 8% of patients taking Nuplazid experienced adverse events, including death, the report stated.

The FDA found that for every 2 patients who had a significant reduction in psychotic events, 1 patient could have a serious adverse event. Ultimately, without any alternatives for treatment options, the panel voted overwhelmingly to endorse the drug.

“Even if the effects are modest you have to compare it with what's available right now, which based on what we've been presented with, is nothing," panel chairman David Brent said in the Associated Press report.

The FDA’s decision on the approval of Nuplazid is scheduled for May 1, 2016.