A supplemental new drug application (sNDA) for pimavanserin (Nuplazid; Acadia Pharmaseuticals, San Diego, CA) was submitted to the Food and Drug Administration (FDA) for a new indication. Evidence now shows pimavanserin is effective for the treatment of hallucinations and delusions associated with dementia-related psychosis (DRP). The FDA previously granted breakthrough therapy designation for pimavanserin.
“This is an important step forward for the approximately 2.4 million people in the US who suffer from dementia-related hallucinations and delusions, representing a large unmet need with currently no approved treatment options,” said Steve Davis, Acadia’s chief executive officer. “Our pivotal Harmony (NCT03325556) study showed a meaningful reduction of the symptoms and stabilization of psychosis and a nearly 3-fold reduction in the risk of relapse of psychosis for patients continuing treatment on pimavanserin compared with placebo. We look forward to working with the FDA as it reviews our submission.”
The sNDA is supported by results from the pivotal phase 3 Harmony study, which demonstrated that pimavanserin significantly reduced the risk of relapse of psychosis by 2.8 more than placebo (hazard ratio = 0.353; 1-sided P=0.0023), which included people with Alzheimer disease (AD) psychosisand Parkinson’s disease (PD) psychosis. The sNDA includes a large safety and tolerability database from completed and ongoing studies representing over 1500 participants with neurodegenerative diseases.
Harmony was a phase 3 study designed to evaluate the efficacy and safety of pimavanserin across a broad population of participants with the most common clinically diagnosed subtypes of dementia. This includes AD, dementia with Lewy bodies, PD dementia, vascular dementia, and frontotemporal dementia spectrum disorders. A total of 392 participants were enrolled in the study, with mean age 74.5 years and a mean Mini-Mental State Examination (MMSE) score of 16.7.
James Geyer, MD, and Paul Cox
Chen Zhao, MD; Claire Flaherty, PhD; Paul J. Eslinger, PhD; and Krishnankutty Sathian, MBBS, PhD
Jennifer Robblee, MD, MSc; Amaal J. Starling, MD; Rashmi B. Halker Singh, MD, FAHS, FAAN; and Nina Riggins, MD, PhD