FDA approves Parkinson's drug
The U.S. Food and Drug Administration approved Nuplazid (pimavanserin) tablets last week as the first approved drug to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson's disease.
Nuplazid is marketed by Acadia Pharmaceuticals Inc. of San Diego.
As many as 50% of patients with Parkinson's disease can experience hallucinations, which can be “profoundly disturbing and disabling,” said Mitchell Mathis, M.D., 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.”
There was a six-week clinical trial of 199 participants where Nuplazid was found to be more effective than a placebo. The most common side effects were swelling, usually in the legs or feet.
The drug was given priority review of the FDA, which is for medications believed to offer a significant improvement in the safety or effectiveness for the treatment, prevention or diagnosis of a serious condition.