The U.S. Food and Drug Administration on Monday accepted Acadia Pharmaceuticals Inc’s application for an antipsychotic drug to treat dementia patients with hallucinations and delusions.
The regulator said it had set April 3, 2021, as the action date to decide on the drug’s approval.
The drug, Nuplazid, was approved in the United States in 2016 for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
In June, Acadia submitted a supplemental new drug application (sNDA) for Nuplazid for the treatment of hallucinations and delusions associated with dementia-related psychosis, which affects about 30% of all patients with dementia in the United States, the company said.
