Nuplazid Gets FDA Go-Ahead

The US Food and Drug Administration (FDA) has approved Nuplazid (pimavanserin) tablets to treat hallucinations and delusions in patients with Parkinson's disease.

Hallucinations or delusions can occur in up to half of patients with Parkinson's, a neurological disease that occurs when dopamine-producing cells in the brain become impaired, according to the FDA. Symptoms include shaking (tremors), sleep disruptions and trouble with movement, among other symptoms.

After Nuplazid appeared more effective than a placebo in a six-week trial of 199 patients, the FDA gave the drug approval. Patients taking Nuplazid saw a decrease in the frequency and/or severity of hallucinations and delusions. Patients did not experience worsening of their primary motor symptoms associated with Parkinson’s disease. 

Nuplazid, which is marketed by Acadia Pharmaceuticals, carries a boxed warning that notes that atypical antipsychotic medications like Nuplazid can increase the risk of death when used to treat older patients with dementia-related psychosis — something for which Nuplazid is not approved.

A confused state, swelling and nausea were among the side effects reported with Nuplazid use.