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PRINCETON & TOKYO – Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical Co. Ltd. reported that their phase 3 clinical trial for the drug AVP-786 did not meet the primary efficacy endpoint in treating agitation in Alzheimer’s disease patients. The trial, known as 17-AVP-786-305, aimed to assess the change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score over 12 weeks, but results did not show a significant difference between AVP-786 and placebo.
During the trial, the incidence of falls was higher in patients treated with AVP-786, with 8.6% in the high dose group and 9.1% in the low dose group, compared to 2.8% in the placebo group. Additionally, there were four deaths reported; one in the AVP-786 low dose group and three in the placebo group.
Otsuka has not yet published the full study results and plans to conduct further analyses to explore the full potential of AVP-786 for treating agitation associated with dementia due to Alzheimer’s disease. The company intends to submit these findings for scientific publication at a future date.
John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka, expressed disappointment in the trial’s outcome but reaffirmed the company’s commitment to analyzing the full data set to understand the future potential of AVP-786. He acknowledged the contributions of study participants, caregivers, and investigators.
Agitation in Alzheimer’s patients is a common and impactful neuropsychiatric symptom, affecting approximately half of all individuals with Alzheimer’s dementia. It encompasses behaviors such as pacing, shouting, and aggression, and is a predictor of nursing home admission.
AVP-786 is a combination drug consisting of deudextromethorphan hydrobromide and quinidine sulfate, designed to increase bioavailability by reducing metabolism by the cytochrome P450 enzyme.