U.S. FDA accepts Acadia’s application for dementia drug

(Reuters) – 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.

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

The application was based on positive results from a late-stage study that showed the drug to be safe and well-tolerated, with few adverse reactions in patients treated with it, the company said.

Separately, Acadia said top-line results from a late-stage study of the same drug as an adjunctive treatment for major depressive disorder (MDD) did not achieve statistical significance on its main goal, adding that it would not pursue additional studies.