New Phase 3 Study Planned for Possible Treatment of Agitation Linked to Alzheimer’s

New Phase 3 Study Planned for Possible Treatment of Agitation Linked to Alzheimer’s
Otsuka Pharmaceutical announced that it and Lundbeck will launch a third Phase 3 clinical trial of brexpiprazole to possibly treat agitation in patients with dementia linked to probable Alzheimer’s disease. Brexpiprazole, under the brand name Rexulti, was approved in the United States to treat people with schizophrenia and as an adjunct treatment for patients with major depressive disorder (MDD) in July 2015. It was approved in Canada and Australia to treat schizophrenia in 2017 and is marketed there under the same brand name. The decision to initiate a third clinical trial follows conversations with the U.S. Food and Drug Administration (FDA) regarding two prior Phase 3 studies (NCT01862640 and NCT01922258) for agitation in people with a diagnosis of probable Alzheimer's, the company said in a press release.  Both were completed this year. The first study evaluated the efficacy, safety and tolerability of two fixed and daily doses of brexpiprazole, 1 or 2 mg, or placebo, and the second evaluated the efficacy, safety and tolerability of 0.5 mg, 1 mg or 2 mg of brexpiprazole or placebo each day. Both trials were randomized and double-blind, and enrolled a total of nearly 700 people between ages 51 and 90 with a diagnosis of probable Alzheimer’s disease (AD) and symptoms of agitation. Top-line results were reported by Lundbeck in May. In both studies, treated patients showed improvements in symptoms of agitation, compared to placebo, as measured by changes from baseline, or study start, in the Cohen-Mansfield Agitation Inventory (CMAI) total score, a 29-item scale to assess agitation. But improvements documented were less robust in the second clinical trial than in the first. Regarding safety and tolerability, both studies confirmed the profi
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