Otsuka Pharmaceutical & Lundbeck Present Positive Data From Multiple Phase 3 Studies Showing Brexpiprazole Significantly Improved Symptoms of Agitation in Patients With Alzheimer’s Dementia at the 2022 Clinical Trials for Alzheimer’s Disease Congress
Otsuka America Pharmaceutical, Inc., (Otsuka) and Lundbeck US (Lundbeck) today presented positive efficacy and safety data from multiple Phase 3 studies of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia at the Clinical Trials for Alzheimer’s Disease (CTAD) Congress in San Francisco, CA
SAN FRANCISCO--(BUSINESS WIRE)--Dec 1, 2022--
Otsuka America Pharmaceutical, Inc., (Otsuka) and Lundbeck US (Lundbeck) today presented positive efficacy and safety data from multiple Phase 3 studies of brexpiprazole in the treatment of agitation in patients with Alzheimer's dementia at the Clinical Trials for Alzheimer’s Disease (CTAD) Congress in San Francisco, CA.
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Data from two Phase 3 studies showed that brexpiprazole 2 mg or 3 mg doses significantly (p<0.05) improved symptoms of agitation in patients with Alzheimer’s dementia compared to placebo. The primary endpoint across the studies was improvement from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score while the key secondary endpoint was an improvement from baseline to week 12 in the Clinical Global Impression-Severity (CGI-S) score related to agitation. Brexpiprazole also demonstrated a favorable safety and tolerability profile in all three studies.
