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ACADIA Pharmaceuticals Announces Pivotal Phase 3 HARMONY Trial Stopped Early for Positive Efficacy as Pimavanserin Meets the Primary Endpoint in Patients with Dementia-Related Psychosis
- Pimavanserin achieved robust statistical superiority over placebo in time to relapse of dementia-related psychosis at planned interim efficacy analysis -
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":"\n- Pimavanserin achieved robust statistical superiority over placebo in time to relapse of dementia-related psychosis at planned interim efficacy analysis\n\n\n- Pimavanserin has the potential to be the first FDA-approved drug for the treatment of dementia-related psychosis\n\n\n- Approximately 1.2 million patients in the United States are diagnosed with dementia-related psychosis\n\n\n- Conference call and webcast to be held today at 8:30 a.m. Eastern Time\n\n SAN DIEGO--(BUSINESS WIRE)--\nACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that its Phase 3 HARMONY study, a double-blind, placebo-controlled relapse prevention trial evaluating pimavanserin for the treatment of dementia-related psychosis, met its primary endpoint, demonstrating a highly statistically significant longer time to relapse of psychosis with pimavanserin compared to placebo in a planned interim efficacy analysis.\n\n\nUpon the recommendation of the study’s independent data monitoring committee, which met to review the data from the planned interim efficacy analysis, the study will now be stopped early based on pre-specified stopping criteria requiring a one-sided p-value less than 0.0033 on the study’s primary endpoint.\n\n\nThe Company is planning to meet with the FDA regarding a supplemental NDA submission in 2020 and the results from the HARMONY study will be submitted for presentation at upcoming medical meetings.\n\n\nThe FDA previously granted Breakthrough Therapy Designation for pimavanserin for the treatment of dementia-related psychosis. No drug is approved by the FDA for the treatment of dementia-related psychosis.\n\n\n“Psychosis adds dramatically to the marked burden that dementia patients already carry and is one of the most challenging-to-manage aspects of the disease for caregivers,” said Jeffrey Cummings, M.D., Sc.D., Director Emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “With no approved treatment options available today for dementia-related psychosis, the pimavanserin study results represent a meaningful advance that will potentially bring us a much needed therapy for this debilitating disease.”\n\n\n“We are very excited that today’s results bring us one step closer to the potential of offering patients with dementia-related psychosis a critically needed treatment option,” said Serge Stankovic, M....