Acadia Is Starting Phase 3 Trial of Nuplazid for Dementia-related Psychosis

Acadia Is Starting Phase 3 Trial of Nuplazid for Dementia-related Psychosis
Acadia Pharmaceuticals is starting its Phase 3 HARMONY trial to evaluate Nuplazid (pimavanserin) as a treatment for hallucinations and delusions associated with dementia-related psychosis. Currently, there is no approved therapy for this condition. Acadia's announcement comes in the wake of the U.S. Food and Drug Administration designating Nuplazid a Breakthrough Therapy, which helps expedite its regulatory review and development. The FDA approved Nuplazid in April 2016 to treat delusions and hallucinations associated with Parkinson's disease psychosis. Dementia-related psychosis includes psychosis in patients with Alzheimer's disease, Parkinson's disease dementia, vascular dementia, dementia with Lewy bodies, and frontotemporal dementia. The global Phase 3 HARMONY trial will evaluate whether Nuplazid, a selective serotonin inverse agonist that targets 5-HT2A receptors, can prevent psychotic symptoms from returning in this patient population. Acadia expects 360 patients to enroll in the study. Acadia said the randomized, double-blind, placebo-controlled trial will be divided into two parts. Part 1 is a 12-week open-label stabilization period, during which patients with dementia-related psychosis will receive 34 mg of Nuplazid once a day, or have their dose readjusted to 20 mg daily, if justified. The second part is a double-blind period, which means that neit
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