Trial 331-14-213 was a Phase 3, multicenter, randomised controlled trial designed to assess the safety, efficacy and tolerability of Brexpiprazole, sponsored by Otsuka Pharmaceuticals and Lundbeck. On 27 June, the two companies published a press release announcing that participants treated with Brexpiprazole had a statistically significant reduction in agitation compared to participants treated with a placebo drug. Brexpiprazole is a drug already approved for the treatment of schizophrenia in the US, Canada and Europe. It is thought to act through interactions with serotonin, dopamine and noradrenaline receptors in the brain. Trial 331-14-213 recruited 345 participants with probable Alzheimer’s dementia (AD) and agitation, administering Brexpiprazole or placebo tablets twice a day for a 12-week period. Participants were based in Bulgaria, Hungary, Serbia, Slovakia, Spain, Ukraine and the USA. Agitation is a prevalent clinical manifestation in Alzheimer’s dementia, and has a large impact on quality of life of patients and caregivers. Early analysis of the trial results showed that participants receiving Brexpiprazole had a reduction in agitation compared to those receiving placebo, based on the Cohen-Mansfield Agitation Inventory (CMAI) questionnaire that assesses the frequency of behaviours such as pacing, restlessness and yelling. Otsuka and Lundbeck are now planning a regulatory filing to the US Food and Drug Administration (FDA) in late 2022, based on the results of this study and two earlier trials. https://www.businesswire.com/news/home/20220627005184/en/Otsuka-Pharmaceutical-and-Lundbeck-Announce-Positive-Results-Showing-Reduced-Agitation-in-Patients-with-Alzheimer%E2%80%99s-Dementia-Treated-with-Brexpiprazole
