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Otsuka and Lundbeck report positive results for the treatment of agitation related to AD

Monday 19 March 2018

Brexpiprazole is currently indicated for the treatment of schizophrenia and major depressive disorder. Global pharmaceutical companies Otsuka and Lundbeck set up two Phase 3 trials to evaluate the safety and efficacy of brexpiprazole in the treatment of people who have agitation related to Alzheimer's disease (AD).

Studies were 12-week, double-blind and randomised trials enrolling approximately 700 participants between 55 and 90 years of age with a diagnosis of probable AD and symptoms of agitation. One trial studied fixed doses of brexpiprazole (1 or 2 mg) and the second evaluated a flexible-dose range (0.25, 0.5, 1 and 2 mg).

Top line results released last year announced that brexpiprazole may reduce agitation in people with AD. On 17 March 2018, findings were presented for the first time at American Association for Geriatric Psychiatry (AAGP) in Honolulu (Hawaii). The drug was well tolerated. Both studies showed a significant improvement in symptoms of agitation compared to placebo in people receiving the drug only at its highest dose 2mg/day.