AVP-786 disappoints in treatment of agitation-associated dementia due to Alzheimer's in initial findings
Agitation associated with dementia caused by Alzheimer's disease is a prevalent neuropsychiatric symptom affecting approximately half of all Alzheimer's dementia patients. This condition substantially impacts the quality of life for patients, their families, and caregivers. Agitation associated with dementia caused by Alzheimer's disease encompasses various behaviors such as pacing, gesturing, profanity, shouting, shoving, and hitting. Additionally, this symptom is a consistent predictor of nursing home admission.
Results from a phase 3 study evaluated the efficacy and safety of AVP-786 for treating agitation associated with dementia due to Alzheimer's disease.
AVP-786 combines deudextromethorphan hydrobromide (d6-DM) and quinidine sulfate (Q), a CYP2D6 inhibitor. Deuteration reduces susceptibility to cytochrome P450 (CYP2D6) enzyme metabolism, increasing bioavailability.
The study included 600+ patients aged 50+ with dementia due to Alzheimer's disease and moderate to severe agitation. In a randomised, double-blind, parallel-design trial, participants received AVP-786 or a placebo twice daily for 12 weeks.
AVP-786 treatment did not significantly improve agitation in dementia patients with Alzheimer's disease, as shown by the change in the Cohen-Mansfield Agitation Inventory total score (primary endpoint). Falls were reported more frequently in the AVP-786 groups (8.6% for high dose, 9.1% for low dose, 2.8% for placebo)
Dr. John Kraus, executive vice president and chief medical officer at Otsuka, mentioned that the complete study findings still need to be released. Further, prespecified and exploratory analyses will be conducted to determine AVP-786's full potential. Otsuka intends to submit the trial results for publication at a later date. They thanked the study participants, their caregivers, and the investigators who participated in this trial.
Otsuka Pharmaceutical Co., Ltd. is a global healthcare corporation dedicated to developing innovative products for better health worldwide. The company focuses on pharmaceutical products to address unmet medical needs and nutraceutical products to maintain everyday health. Otsuka is a leader in mental, renal, and cardiovascular health and also has research programs in oncology and under-addressed diseases like tuberculosis.
References:
Otsuka announces phase 3 topline results of AVP-786 in the treatment of agitation associated with dementia due to Alzheimer's disease. News release. Otsuka Pharmaceutical. February 12, 2024. Accessed February 13, 2024. https://www.businesswire.com/news/home/20240212652874/en/Otsuka-Announces-Phase-3-Topline-Results-of-AVP-786-in-the-Treatment-of-Agitation-Associated-With-Dementia-Due-to-Alzheimer%E2%80%99s-Disease.
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