Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC) and its parent company Otsuka Pharmaceutical, Co. Ltd. (Otsuka) have released the topline results of the phase 3 clinical trial of AVP-786 in the treatment of 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, 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 placebo; 16 (8.6%) in the AVP-786 high dose group, 18 (9.1%) in the AVP-786 low dose group, and 6 (2.8%) in the placebo group. Additionally, there were 4 deaths reported in the trial; 1 (0.5%) in the AVP-786 low dose group and 3 (1.4%) in the placebo group.

Full study results are pending. Further prespecified and exploratory analyses of the dataset will be conducted to ascertain the complete potential of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease. Otsuka intends to submit the trial results for scientific publication at a later date.

Dr. John Kraus, Executive Vice President and Chief Medical Officer at Otsuka, commented, “While the result of this trial is disappointing, we plan to analyze the full data set to determine the future potential of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer’s disease. In 2023, Otsuka became the first company to get a drug approved for this patient population and we are committed to expanding and innovating in this area. We are deeply grateful to all of the study participants, their caregivers, and the investigators who took part in this trial and contributed to this research.”