ACADIA Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its supplemental New Drug Application (sNDA) for NUPLAZID® (pimavanserin) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA has assigned a standard review with Prescription Drug User Fee Act action date of April 3, 2021.
The FDA has also informed the company that it has not identified any potential review issues at this point in their evaluation and at this time they are not planning to hold an Advisory Committee meeting. The sNDA is supported by results from the pivotal Phase 3 HARMONY study, which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared to placebo. The sNDA also includes positive efficacy results from two additional placebo-controlled studies, both of which met their respective primary endpoints, through a study in individuals with Alzheimer’s disease psychosis and Parkinson’s disease psychosis. The sNDA includes a large safety database from completed and ongoing studies representing over 1,500 consumers with neurodegenerative disease.
Acadia Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system disorders. ACADIA has developed and commercialized the first and only medicine approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis. ACADIA’s development efforts are focused on pimavanserin for additional neuropsychiatric conditions, trofinetide for Rett syndrome, and an early-stage muscarinic receptor program.
This was reported by Acadia Pharmaceuticals Inc. on July 20, 2020.
Contact information: Eric Endicott, Vice President, Corporate Communications, Acadia Pharmaceuticals Inc., 3611 Valley Centre, Drive, Suite 300, San Diego, California 92130; 858-914-7161; Email: email@example.com; Website: www.acadia-pharm.com