The FDA has approved Acadia Pharmaceuticals' pimavanserin (Nuplazid), the first drug that can help treat hallucinations and delusions associated with psychosis experienced by some patients with Parkinson's disease.
The FDA has approved Acadia Pharmaceuticals’ pimavanserin (Nuplazid), the first drug that can help treat hallucinations and delusions associated with psychosis experienced by some patients with Parkinson’s disease.
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Mitchell Mathis, director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research, in a press release. “Nuplazid represents an important treatment for people with Parkinson’s disease who experience these symptoms.”
The approval is based on data from a 6-week clinical trial of 199 patients. In the study, Nuplazid proved that it was superior to placebo in decreasing the frequency or severity of hallucinations. Additionally, it did not worsen the motor symptoms of Parkinson’s disease.
The hallucinations and delusions associated with the condition can lead to impaired thinking and emotions that may prevent patients from relating to love ones well or from taking appropriate care of themselves.
The most common adverse effects associated with Nuplazid include swelling, nausea, and abnormal state of mind. Swelling may occur in the ankles, legs, and feet due to accumulation of excessive fluid.
Nuplazid carries a boxed warning for an increased risk of death associated with the use of the drug to treat older patients with dementia-related psychosis.
Approximately 50,000 Americans are diagnosed with Parkinson’s disease each year.