FDA Approves Nuplazid for Parkinson's Hallucinations

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FDA Approves Nuplazid for Parkinson's Hallucinations
FDA Approves Nuplazid for Parkinson's Hallucinations

MONDAY, May 2, 2016 (HealthDay News) -- Nuplazid (pimavanserin) has been approved by the U.S. Food and Drug Administration to treat hallucinations and delusions associated with Parkinson's disease.

As many as half of patients with Parkinson's may have psychosis that lead to hallucinations and delusions, the agency said in a news release announcing the approval. This can lead to behaviors including difficulty associating with loved ones or the inability to take care of oneself.

In clinical studies involving 199 people, Nuplazid was shown to be superior to placebo in decreasing the frequency and/or severity of hallucinations and delusions without worsening the primary motor symptoms of Parkinson's disease. The most common side effects included peripheral edema, nausea, and confusion.

The drug, as with other atypical antipsychotics, includes a boxed label warning of an increased risk of death among older people with dementia-related psychosis. Atypical antipsychotics are not approved to treat dementia-related psychosis, the FDA stressed.

Nuplazid is marketed by San Diego-based Acadia Pharmaceuticals.

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