Otsuka Pharmaceutical Co., Ltd. (Otsuka) and H. Lundbeck A/S (Lundbeck) announce that the two companies will initiate a third clinical phase 3 study for brexpiprazole in the treatment of agitation in patients with dementia of the Alzheimer's type. The trial is expected to commence during the first half of 2018.

The decision to initiate a third trial follows discussions with the U.S. Food and Drug Administration (FDA) regarding two phase 3 clinical trials for the agitation indication that were completed by Otsuka and Lundbeck earlier this year. Top-line results for the two completed trials were announced in May 2017.