Otsuka’s Phase 3 Trial for AVP-786 Fails in Treating Agitation in Alzheimer’s Patients
Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka Pharmaceutical Co. Ltd. have announced that their phase 3 clinical trial for the drug AVP-786 has not met the primary efficacy endpoint in treating agitation in patients with Alzheimer’s disease.
The trial, known as 17-AVP-786-305, aimed to evaluate the change from baseline in the Cohen-Mansfield Agitation Inventory (CMAI) total score over a span of 12 weeks. However, the results did not show a significant difference between patients treated with AVP-786 and those who received a placebo.
During the trial, it was observed that the incidence of falls was higher in patients who were treated with AVP-786. In the high dose group, 8.6% experienced falls, while in the low dose group, the figure stood at 9.1%. In comparison, only 2.8% of the patients in the placebo group encountered falls. Furthermore, the trial also reported four deaths, with one occurring in the AVP-786 low dose group and three in the placebo group.
Otsuka has not yet released the full study results and plans to conduct further analyses to explore the potential of AVP-786 in treating agitation associated with Alzheimer’s disease. The company intends to submit these findings for scientific publication at a later date.
John Kraus, M.D., Ph.D., executive vice president and chief medical officer at Otsuka, expressed disappointment in the outcome of the trial. Nonetheless, he emphasized the company’s commitment to thoroughly analyzing the full data set to fully understand the future potential of AVP-786. He also acknowledged the invaluable contributions of the study participants, caregivers, and investigators.
Agitation is a distressing neuropsychiatric symptom commonly observed in patients with Alzheimer’s disease, impacting approximately half of all individuals with the condition. It manifests in behaviors such as pacing, shouting, and aggression, and has been identified as a predictor of admission to nursing homes.
AVP-786, a combination drug comprising deudextromethorphan hydrobromide and quinidine sulfate, is specifically designed to enhance bioavailability by reducing metabolism through the cytochrome P450 enzyme.
While this trial did not yield the desired outcome, Otsuka remains dedicated to unraveling the potential benefits of AVP-786 in addressing agitation associated with dementia due to Alzheimer’s disease. The company’s commitment to ongoing research highlights their determination to provide effective treatment options for patients in need.
Analyst comment
Negative news: Otsuka’s Phase 3 Trial for AVP-786 Fails in Treating Agitation in Alzheimer’s Patients.
As an analyst, the market reaction is expected to be negative. The failure of the trial to meet the primary efficacy endpoint and the higher incidence of falls and deaths in the AVP-786 group are concerning. However, Otsuka’s commitment to further analysis and ongoing research shows their dedication to finding effective treatment options.
