FDA Okays Pimavanserin for Hallucinations, Delusions in PD

Susan Jeffrey


April 29, 2016

The US Food and Drug Administration (FDA) has approved pimavanserin tablets (Nuplazid, Acadia Pharmaceuticals) for the treatment of hallucinations and delusions associated with psychosis in Parkinson's disease (PD).

Hallucinations or delusions occur in as many as 50% of patients with PD at some time 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 in a statement. "Nuplazid represents an important treatment for people with Parkinson's disease who experience these symptoms."

The effectiveness of pimavanserin was shown in a 6-week clinical trial of 199 participants, where it was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor PD symptoms.

The FDA's Psychopharmalogic Drugs Advisory Committee gave the drug the green light on March 30. Despite some concerns about an increased risk for severe adverse events, including death, and the small number of patients tested, committee members determined that Acadia had shown its drug to be effective and safe and that its benefits outweigh the risks.

The committee voted 12 to 2 that the sponsor provided sufficient evidence of efficacy, 11 to 3 that safety was sufficiently characterized, and 12 to 2 that the drug's benefits outweigh its risks.

As with other atypical antipsychotic drugs, pimavanserin has a boxed warning alerting healthcare professionals about an increased risk for death associated with the use of these drugs to treat older people with dementia-related psychosis. No drug in this class is approved to treat patients with dementia-related psychosis, the FDA statement notes.

In clinical trials, the most common adverse effects reported were swelling, usually of the ankles, legs, and feet as a result of peripheral edema; nausea; and confused state.

Pimavanserin was granted breakthrough therapy designation for the treatment of hallucinations and delusions associated with PD. "Breakthrough therapy designation is a program designed to expedite the development and review of drugs that are intended to treat a serious condition and where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint," the FDA statement said.

The drug was also granted a priority review. "The FDA's priority review program provides for an expedited review of drugs that offer a significant improvement in the safety or effectiveness for the treatment, prevention, or diagnosis of a serious condition," the statement notes.

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