Resubmission of sNDA to FDA for Nuplazid to treat Alzheimer’s disease psychosis.
Acadia Pharmaceuticals Inc. announced that it has resubmitted its supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP) to the FDA.
This resubmission is in response to the FDA’s April 2, 2021, Complete Response Letter (CRL) to the sNDA originally submitted for a proposed indication for pimavanserin for the treatment of dementia-related psychosis.
The resubmission provides additional analyses from two previously conducted clinical studies, HARMONY1 and Study -0192, to support a proposed indication for the treatment of ADP and is intended to address the issues raised in the FDA’s CRL.
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