HLUYY - Lundbeck Otsuka drug helps reduce agitation in Alzheimer's dementia patients in trial

Denmark-based H. Lundbeck (OTCPK:HLUYY) (OTC:HLUKF) and Japan's Otsuka (OTCPK:OTSKF) (OTCPK:OTSKY) said their medicine brexpiprazole helped reduce agitation, compared to placebo, in patients with Alzheimer's dementia in a phase 3 trial. The companies aid based on the outcome are planning a regulatory filing to the FDA later in 2022. A supplemental new drug application (sNDA) will consist of this study and two earlier trials. The study, dubbed 331-14-213, evaluated two fixed doses of brexpiprazole (2 mg/day and 3 mg/day) against placebo to treat patients with agitation in Alzheimer’s dementia. The study included 345 patients, aged 55–90 years The main goal of the study was change in a rating scale that measures agitation. The companies said that data showed that improvements from baseline to week 12 in agitation were greater in those receiving any of the two doses of brexpiprazole, compared to those on placebo. In addition, data also showed a statistically superior improvement on the secondary goal

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Lundbeck, Otsuka drug helps reduce agitation in Alzheimer’s dementia patients in trial