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# FDA OKs Acadia NDA for Parkinson’s Drug
- URL: https://www.fdaweb.com/fda-oks-acadia-nda-for-parkinsons-drug/
- Published: 2016-05-02T12:00:00.000Z
- Updated: 2026-09-14T20:58:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135548

> FDA has approved an Acadia Pharmaceuticals NDA for Nuplazid (pimavanserin) tablets, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson’s disease. “Hallucinations or delusions can occur in as many as 50% of patients with Parkinson’s disease at some time during the course of their illness,” an agency release says. “The hallucinations and delusions experienced with Parkinson’s disease are serious symptoms, and can lead to thinking and emotions that are so impaired that the people experiencing them may not relate to loved ones well or take appropriate care of themselves.” The approval follows a 3/29 FDA Psychopharmacologic Drugs Advisory Committee meeting that voted 12 to 2 to support approval ([see story](https://www.fdaweb.com/acadia-parkinsons-psychosis-drug-doesnt-worsen-disease-fda/)).  
>  
> Approval was based on data from a six-week clinical trial involving 199 participants. Nuplazid was shown to be superior to placebo in reducing hallucinations and delusions without worsening the primary motor symptoms of Parkinson’s disease, FDA says. “As with other atypical antipsychotic drugs, Nuplazid has a Boxed Warning alerting health care professionals about an increased risk of death associated with the use of these drugs to treat older people with dementia-related psychosis,” it adds.