FDA Rejects Pimavanserin sNDA for Dementia-Related Psychosis

FDA Rejects Pimavanserin sNDA for Dementia-Related Psychosis
The Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Acadia Pharmaceuticals regarding the supplemental New Drug Application (sNDA) for pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis. The sNDA submission was supported by data from the pivotal phase 3 HARMONY study (ClinicalTrials.gov: NCT03325556) that compared the efficacy and safety of pimavanserin, ... read more
Source: Neurology AdvisorPublished on 2021-04-08By Steve Duffy