Posted by Michael Wonder on 05 Aug 2022
Acadia Pharmaceuticals receives complete response letter from U.S. FDA for supplemental new drug application for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis
4 August 2022 - Acadia Pharmaceuticals today announced that the company has received a complete response letter from the U.S. FDA regarding its supplemental new drug application for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis.
The letter indicated that the FDA has completed review of the application, determining that it could not approve the supplemental new drug application in its present form, and recommended that Acadia conduct an additional trial in Alzheimer’s disease psychosis.
