FDA Approves First Psychosis Medication for Parkinson's Disease

The FDA recently approved Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson’s disease-related psychosis.

According to the FDA, approximately 50% of patients with Parkinson’s disease experience some sort of hallucination or delusions during the course of their illness.

“Hallucinations and delusions can be profoundly disturbing and disabling,” said Mitchell Mathis, MD, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”

A 6-week clinical trial evaluated the efficacy of Nuplazid in 199 patients. Researchers found the drug to be superior to placebo in decreasing the frequency or the severity of hallucinations and delusions without worsening the symptoms of Parkinson’s disease.

As with many other antipsychotic drugs, there is an increased risk of death associated with the use of this drug to treat psychosis in older people.

The most common adverse effects seen in the trial were swelling, nausea, and a confused state of mine.

The drug was previously granted breakthrough therapy designation and priority review by the FDA.