Otsuka, Lundbeck initiate a third trial of Rexulti for agitation in Alzheimer’s disease

Otsuka Pharmaceutical/Lundbeck recently announced the initiation of a third phase 3 trial to determine efficacy of Rexulti for treatment of agitation in Alzheimer’s disease.

Rexulti (brexpiprazole, Otsuka) is currently approved for treatment of schizophrenia and as adjunctive treatment for major depression.

The decision to begin a third trial followed discussions with the FDA about two phase 3 clinical trials completed by Otsuka Pharmaceutical/Lundbeck previously in 2017.

These trials were randomized, double-blind, placebo-controlled studies conducted among approximately 700 individuals. Study participants were aged 51 to 90 years and diagnosed with probable Alzheimer’s disease and symptoms of agitation. The cohort included both outpatients and individuals living in institutional care settings. One trial assessed fixed doses of 1 mg or 2 mg of brexpiprazole or placebo per day, while the other studied flexible-dose ranges of 0.5 mg, 1 mg, or 2 mg of brexpiprazole or placebo per day. Study duration was 12 weeks.

In the first study, participants who received 2 mg of brexpiprazole exhibited greater improvements in Cohen-Mansfield Agitation Inventory (CMAI) total scores, compared with the placebo group (P < .05).

Improvements in CMAI scores were greater than improvements in Clinical Global Impression-Severity of Illness (CGI-S) scores among participants who received 2 mg of brexpiprazole in the first study.

In the second study, improvements in CMAI (P > .05) were less robust than improvements in CGI-S (P < .05), according to researchers.

The most common adverse events among participants who received brexpiprazole were insomnia (4.7% vs. 3.3%), agitation (3.5% vs. 2.9%) and somnolence (3.3% vs. 2.2%), compared with the placebo group.

The third trial is projected to commence during the first half of 2018.