On 25 March, Otsuka Pharmaceutical Co., Ltd. announced that its subsidiary Avanir Pharmaceuticals reported results from its Phase III clinical trial evaluating AVP-786 for the treatment of agitation in people with Alzheimer's dementia.
The Phase III trial (15-AVP-786-301) is a multicenter, randomised, double-blind and placebo-controlled study evaluating the efficacy, safety and tolerability of AVP-786 for the treatment of moderate-to-severe agitation in people with Alzheimer's dementia. The study enrolled 410 US participants aged 50 to 90 with moderate-to-severe agitation and probable Alzheimer's dementia.
Data showed a significant improvement on the primary endpoint on the Cohen-Mansfield Agitation Inventory for one of the two doses being evaluated. Similar improvements were also reported on the secondary outcome measures. The most common side effects that occurred in participants receiving AVP-786 versus placebo were falls, urinary tract infection, headache and diarrhoea.
https://www.otsuka.co.jp/en/company/newsreleases/2019/20190325_2.html
