The Food and Drug Administration (FDA) has accepted for filing its supplemental new drug application (sNDA) for pimavanserin (Nuplazid; Acadia Pharmaceuticals, San Diego, CA) for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP).
The sNDA is supported by results from the pivotal phase 3 Harmony study (NCT03325556), which met its primary endpoint, demonstrating that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 fold compared with placebo (hazard ratio = 0.353; P=0.0023). The sNDA also includes positive efficacy results from 2 additional placebo-controlled studies, both of which met their respective primary endpoints: the phase 2 (-019) study in participants with Alzheimer disease (AD) psychosis and the phase 3 (-020) study in participants with Parkinson disease (PD) psychosis. The sNDA includes a large safety database from completed and ongoing studies representing over 1500 participants with neurodegenerative disease.
“We are pleased that the FDA has accepted our sNDA for filing and we will be working closely with the FDA to facilitate completion of the review in a timely manner,” said Steve Davis, Acadia’s chief executive officer. “If approved, Nuplazid would be the first therapy indicated for the treatment of hallucinations and delusions associated with dementia-related psychosis. We look forward to potentially bringing this important treatment advancement to patients, caregivers and physicians.”
The FDA has assigned a standard review with a prescription drug user fee act (PDUFA) 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.
Michelle L. Dougherty, MD, FAES, FAAN
David Z. Rose, MD
Danielle S. Shpiner, MD; Crystal Dixon, MD; Melissa R. Ortega, MD; and Henry Moore, MD