Pimavanserin, currently approved by the US Food and Drug Administration (FDA) for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis, reduced the risk of psychosis relapse 2.8-fold in patients with dementia.
The study results were presented at the 12th Clinical Trials on Alzheimer’s Disease Meeting in San Diego, California, December 4-7, 2019.
“The results presented today are an important advance for patients and caregivers who struggle with the burden of dementia-related psychosis where no FDA-approved treatment is currently available,” said Jeffrey Cummings, MD, ScD, director emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas, Nevada.
“Reducing the risk of relapse of psychotic symptoms by this magnitude is an important and meaningful outcome, as these are serious events which could lead to poor patient outcomes and a significant increase in caregiver burden and distress.”
The phase 3 HARMONY study included 392 patients with dementia-related psychosis. The study began with a 12-week open-label period. Afterward, patients who responded to pimavanserin were randomized into a double-blind study period to continue their pimavanserin dose or switch to placebo. Participants were followed for an additional 26 weeks or until psychosis relapse.
By significantly reducing the risk of psychosis relapse by 2.8-fold compared with placebo, pimavanserin met the primary endpoint of the relapse-prevention study, researchers reported. In addition, pimavanserin significantly reduced the risk of discontinuation for any reason by 2.2-fold, effectively meeting the study’s key secondary endpoint.
The FDA previously granted pimavanserin a Breakthrough Therapy designation for the treatment of dementia-related psychosis. Acadia Pharmaceuticals Inc. said it plans to meet with the FDA in the first half of 2020 about a supplemental New Drug Application submission.
ACADIA Pharmaceuticals presents positive top-line results from pivotal phase 3 HARMONY trial of pimavanserin in patients with dementia-related psychosis at 12th Clinical Trials on Alzheimer’s Disease (CTAD) meeting [press release]. San Diego, California: ACADIA Pharmaceuticals Inc.; December 4, 2019.