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

• Researchers highlight efficacy and safety data across three Phase 3 studies of brexpiprazole for agitation in Alzheimer’s dementia
• Agitation is a highly prevalent clinical manifestation in Alzheimer’s dementia and one of the most complex and stressful aspects of care in patients affected by the disease. It is associated with greater caregiver burden, earlier nursing home placement, increased morbidity and mortality, and a substantial economic burden
• There are no FDA-approved pharmacological treatments for agitation in Alzheimer’s dementia

Excerpt from the Press Release:

SAN FRANCISCO–(BUSINESS WIRE)–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.

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.

“Agitation in Alzheimer’s dementia represents an incredibly complex and challenging aspect of care in patients affected by the disease,” said Robert McQuade, PhD, executive vice president, chief strategy officer, Otsuka Pharmaceutical Development & Commercialization, Inc. “We’re proud to share this positive data from our Phase 3 double-blind trials that showcase our commitment to address current unmet needs and deliver a first-of-its-kind pharmacological treatment for agitation in Alzheimer’s dementia to patients and their caregivers.”

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