FDA approves Nuplazid (pimavanserin) for hallucinations and delusions in Parkinson's disease- Acadia Pharmaceuticals

The FDA has approved Nuplazid (pimavanserin) tablets, from Acadia Pharmaceuticals, the first drug approved to treat hallucinations and delusions associated with psychosis experienced by some people with Parkinson's disease. The effectiveness of Nuplazid was shown in a six-week clinical trial of 199 participants. 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.

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. No drug in this class is approved to treat patients with dementia-related psychosis. In clinical trials, the most common side effects reported by participants taking Nuplazid were: swelling, usually of the ankles, legs, and feet due to the accumulation of excessive fluid in the tissue (peripheral edema); nausea; and abnormal state of mind (confused state).

Comment: Pimavanserin is Acadia proprietary small molecule that acts selectively as an antagonist/inverse agonist on serotonin 5-HT2A receptors and can be taken orally as a tablet once-a-day.