Nuplazid ‘Encouraging’ in Lowering Dementia-related Psychosis Risk, HARMONY Trial Finds

Nuplazid ‘Encouraging’ in Lowering Dementia-related Psychosis Risk, HARMONY Trial Finds
[Editor's note: This story, published on Dec. 10, was updated on Dec. 16 with additional details provided by Acadia Pharmaceuticals.] People with Alzheimer’s and other dementias treated with Nuplazid (pimavanserin) in a Phase 3 trial were almost three times less likely to have a psychosis relapse — a worsening of delusions and hallucinations — than others, HARMONY trial data show. HARMONY met its main goal, significantly lowering the risk of a psychosis relapse by 2.8 times compared to placebo, and also found most patients unlikely to discontinue Nuplazid’s use for any reason. Based on these findings, Acadia Pharmaceuticals, the manufacturer of Nuplazid, plans to meet with the U.S. Food and Drug Administration early next year to discuss the possibility of extending the medicine’s use to include these patients. If FDA approval is given, Nuplazid will be the first targeted therapy for dementia-associated psychosis. Trial results were detailed in “HARMONY Relapse-Prevention Study: Pimavanserin Significantly Prolongs Time to Relapse of Dementia-Related Psychosis,” given by Erin Foff, MD, PhD, Acadia’s clinical director, in a late-breaking communication at the 12th Clinical Trials on Alzheimer’s Disease (CTAD) Meeting, held Dec. 4–7 in San Diego. Foff called the results "very encouraging," a much-needed alternative to the off-label treatment now used. “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,” Jeffrey Cummings, MD, director emeritus of Cleveland Clinic Lou Ruvo Center for Brain Health, said in a press release.  “Reducing the risk of relapse of psychotic symptoms by this ma
Subscribe or to access all post and page content.