24 January 2024 - Otsuka Pharmaceutical Canada and Lundbeck Canada announce that Health Canada has issued a Notice of Compliance for Rexulti (brexpiprazole) for use in the symptomatic management of agitation associated with Alzheimer's dementia in patients with aggressive behaviour, unresponsive to non-pharmacological approaches.

The approval was based on three Phase 3, 12 week, randomised, double-blind, placebo-controlled studies (two fixed-dose and one flexible dose) that evaluated the frequency of agitation symptoms in patients with dementia due to Alzheimer's disease based on the Cohen-Mansfield Agitation Inventory total score.

Read Otsuka press release