Otsuka and Lundbeck announced top-line results from two Phase 3 trials of brexpiprazole for the treatment of agitation in patients with dementia of the Alzheimer’s type.

The studies were both 12-week, randomized, double-blind, placebo-controlled trials evaluating efficacy, safety and tolerability of brexpiprazole in approximately 700 patients with a diagnosis of probable Alzheimer’s disease and symptoms of agitation. One study evaluated fixed doses of brexpiprazole (1mg or 2mg daily), while the other trial evaluated a flexible-dose range (0.5mg, 1mg, 2mg daily), both compared to placebo.

Their primary endpoint was change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score, a 29-item scale to systematically assess the symptoms of agitation. The key secondary endpoint was the change from baseline in the Clinical Global Impression-Severity of Illness (CGI-S) score, a 7-point scale assessing overall severity of the patient’s agitation.

Results from both studies demonstrated that treatment with brexpiprazole showed improvements in symptoms of agitation compared to placebo. The first study showed statistically better improvement in the primary endpoint of CMAI for brexpiprazole 2mg vs. placebo (P<0.05), which appeared more robust than the improvements on the key secondary endpoint of CGI-S (P>0.05). The second study showed statistically significant improvement in the CGI-S score (P<0.05), but showed less robust improvements in the CMAI total score (P>0.05). 

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Both studies confirmed the safety and tolerability profile of brexpiprazole as observed in the schizophrenia and major depressive disorder (MDD) studies. The most common adverse events reported for brexpiprazole vs. placebo were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%), and somnolence (3.3% vs. 2.2%). Detailed findings from both trials will be presented in scientific congresses over the next year.

Brexpiprazole, an atypical antipsychotic, is approved under the brand name Rexulti and currently indicated for the treatment of schizophrenia and as an adjunct treatment for MDD.

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