Otsuka Pharmaceutical Co., Ltd.

November 17, 2015

Otsuka Pharmaceutical Affiliate Avanir Pharmaceuticals Announces Initiation of Phase III Trial of AVP-786 for Agitation in Patients with Alzheimer's Disease

Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that U.S. subsidiary Avanir Pharmaceuticals (Avanir) has initiated patient enrollment in the first of two phase III clinical trials in the U.S. to evaluate a new agent, AVP-786. The new agent's main component is deuterated dextromethorphan (DM), for the treatment of agitation in patients with Alzheimer's disease. This clinical trials recently were granted "Fast Track" status (priority approval system) by the U.S. Food and Drug Administration.

About AVP-786

AVP-786 is a combination of deuterated dextromethorphan and low-dose quinidine. Quinidine inhibits the metabolic enzyme CYP2D6 in the liver, to elevate the availability of DM within the blood.

About Agitation in Alzheimer's Disease

About 50% of patients suffering from Alzheimer's disease exhibit behavioral symptoms such as confusion, as well as verbal abuse and even violence against their caregivers. These behavioral symptoms increase the burden on caregivers, whether trained professionals or family members. As symptoms and cognitive function deteriorate further institutional care may become necessary.

About Avanir and Otsuka's Research and Development in Alzheimer's Disease

Avanir has leveraged its experience in the research and development of DM-based compounds for behavioral disorders into the new area of Alzheimer's disease. Future development will involve initiation of a second phase III trial of AVP-786 in the U.S. and global trials. These multicenter, randomized, placebo-controlled trials will examine the efficacy, safety and tolerability of the agent in the treatment of behavioral disorders related to agitation in Alzheimer's disease. For details on the phase III trial now underway, please refer to the website (NCT02442765 is the identifier).
Otsuka is pursuing Alzheimer's disease-related research as a crucial area of patient need and has two compounds in late-stage development in addition to the Avanir compound.