The US FDA Rejects Expanded Use Of Acadia’s Antipsychotic Drug

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. (Andrew Kelly/Reuters)

The U.S. Food and Drug Administration has declined to allow Acadia Pharmaceuticals Inc to expand its use of Acadia’s antipsychotic drug to treat psychosis associated with Alzheimer’s Disease, Acadia Pharmaceuticals Inc said Thursday.

The health regulator determined that Acadia’s study of antipsychotic drugs was difficult to interpret and that additional studies would be needed.

The U.S. regulator made the decision about a month ago after its panel of advisors decided 9-3 that there was no evidence to support that pimavanserin is effective in treating hallucinations or delusions related to Alzheimer’s disease.

” We are disappointed by this result. Steve Davis, Acadia chief executive officer said that the treatment of Alzheimer’s disease psychosis remains a high-unmet area with no approved therapies.

This Acadia’s second attempt at obtaining approval for the expanded use of this drug. Acadia was informed by the FDA in April 2021, that its clinical trials data were not enough to approve pimavanserin for dementia-related psychosis patients.

The company submitted its February application again with an emphasis on Alzheimer’s patients.

The drug, sold under the brand name Nuplazid, is already approved for a similar indication in patients with Parkinson’s disease and brought in sales of $484 million last year.