Posted by Michael Wonder on 16 Jun 2020
Acadia Pharmaceuticals submits supplemental new drug application to U.S. FDA for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis
15 June 2020 - Submission based on positive results from the Phase 3 HARMONY study which showed a statistically significant 2.8 fold reduction in the risk of relapse of psychosis.
ACADIA Pharmaceuticals announced today that the company submitted a supplemental new drug application to the U.S. FDA to support a potential new indication for Nuplazid (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).
The FDA previously granted breakthrough therapy designation for pimavanserin for the treatment of hallucinations and delusions associated with DRP.
