Otsuka Pharmaceutical and Lundbeck have announced positive Phase 3 clinical trial results for brexpiprazole, aimed at treating agitation in Alzheimer’s dementia. In a double-blind study with 345 participants, treatment with brexpiprazole showed a statistically significant reduction in agitation compared to placebo. Agitation is a common symptom affecting 45% of Alzheimer’s patients, leading to increased caregiver burden and health risks. The data will support a Supplemental New Drug Application to the FDA, which previously granted brexpiprazole fast track designation for this indication.
Otsuka Pharmaceutical and H. Lundbeck A/S announced positive findings from a Phase 3 study of brexpiprazole targeting agitation in Alzheimer's dementia. The results, to be presented at the 2022 Alzheimer’s Association International Conference on August 4, highlight a potential treatment option for a significant unmet medical need, as no FDA-approved drugs currently exist for this condition. The study aims to improve the quality of life for patients and caregivers facing this prevalent issue.
Otsuka Pharmaceutical and Lundbeck have announced positive Phase 3 clinical trial results for brexpiprazole in treating agitation in patients with Alzheimer’s dementia. The study showed a statistically significant reduction in agitation compared to placebo (p=0.0026). Agitation affects approximately 45% of Alzheimer’s patients, leading to increased caregiver burden. Despite no FDA-approved treatments currently available, the results pave the way for a Supplemental New Drug Application (sNDA) to the FDA by late 2022, based on this and two previous trials.
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