Otsuka Reveals Phase 3 Topline Findings for AVP-786 in Treating Agitation Linked to Alzheimer’s Disease Dementia

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and its parent company, Otsuka Pharmaceutical Co., Ltd. (Otsuka), have disclosed the topline findings from the phase 3 clinical trial of AVP-786 aimed at treating agitation associated with dementia due to Alzheimer’s disease (Trial 17-AVP-786-305; NCT03393520). The trial did not achieve a statistically significant difference on the primary efficacy endpoint, which measures the mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) total score between AVP-786 and placebo.

During the trial, one treatment-emergent adverse event—a fall—occurred with an incidence rate of more than 5% in patients treated with AVP-786 compared to the placebo group. Specifically, there were 16 cases (8.6%) in the AVP-786 high dose group, 18 cases (9.1%) in the AVP-786 low dose group, and 6 cases (2.8%) in the placebo group. Additionally, there were 4 reported deaths in the trial: 1 (0.5%) in the AVP-786 low dose group and 3 (1.4%) in the placebo group.

While complete study results are pending, further analyses of the dataset will be conducted to explore the full potential of AVP-786 in treating agitation associated with dementia due to Alzheimer’s disease. Otsuka plans to submit the trial results for scientific publication at a later date.

Commenting on the outcome, John Kraus, M.D., Ph.D., Executive Vice President and Chief Medical Officer at Otsuka, expressed disappointment but emphasized the company’s commitment to evaluating AVP-786’s future potential in this therapeutic area. He acknowledged the contribution of study participants, caregivers, and investigators to the research.

Agitation associated with dementia due to Alzheimer’s disease is a prevalent neuropsychiatric symptom affecting approximately half of all Alzheimer’s dementia patients, significantly impacting their quality of life and that of their caregivers. Symptoms range from pacing and gesturing to profanity and physical aggression, often leading to nursing home admission.

AVP-786 is a combination of deudextromethorphan hydrobromide (d6-DM) and quinidine sulfate (Q), designed to reduce susceptibility to cytochrome P450 (CYP2D6) enzyme metabolism and increase bioavailability.

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company dedicated to developing innovative products to address unmet medical needs. Its U.S. affiliates, including OPDC and Otsuka America Pharmaceutical, Inc. (OAPI), focus on mental health and nephrology, striving to advance healthcare through cutting-edge technology and research.

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