Otsuka set for $770-million charge on study failure of Alzheimer’s disease agitation drug

2024-02-13

临床3期上市批准并购临床结果财报

Otsuka announced that its investigational oral therapy AVP-786 (deudextromethorphan/quinidine) for the treatment of agitation associated with dementia due to Alzheimer’s disease missed the primary endpoint of a Phase III trial.

“While the result of this trial is disappointing,” said chief medical officer John Kraus, “we are committed to expanding and innovating in this area.” Ahead of its financial results, the company revised its consolidated forecasts for 2023, anticipating an impairment loss of approximately JPY 115 billion ($770 million) on AVP-786 in the fourth quarter.

The drug became part of Otsuka’s Alzheimer’s disease portfolio through its acquisition of Avanir Pharmaceuticals for $3.5 billion in late 2014. The portfolio currently features Rexulti (brexpiprazole), jointly marketed by Lundbeck, which secured FDA approval for treating agitation in Alzheimer's disease in May last year, making it the first treatment authorised for this indication in the US.

According to ClinicalTrials.gov, the trial investigated twice-daily AVP-786 across two dose levels, in approximately 550 patients with agitation associated with Alzheimer's type dementia. Otsuka noted that AVP-786 failed to show a statistically significant difference over placebo in the primary efficacy endpoint, the mean change from baseline to week 12 in the Cohen-Mansfield Agitation Inventory total score.

In terms of safety, treatment-emergent adverse events were observed at rates of 8.6% and 9.1% in the high and low dose AVP-786 groups, respectively, compared with 2.8% in the placebo group. Additionally, four deaths were reported during the study – one in the AVP-786 low dose group and three in the placebo group.The company intends to conduct further analyses of the full dataset.

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机构

Otsuka Holdings Co., Ltd.