Policy & Regulation
Lundbeck and Otsuka proceed with full phase III trial of brexpiprazole for agitation in Alzheimer's dementia
13 April 2021 -

H. Lundbeck A/S (CPH:LUN), a global pharmaceutical company specialised in brain diseases, and Otsuka Pharmaceutical Co Ltd, a subsidiary of Japan's Otsuka Holdings Co Ltd (TYO:4578), said on Tuesday that they will continue to recruit patients for the phase III clinical trial evaluating brexpiprazole for the treatment of agitation in patients with Alzheimer's-type dementia.

The trial is designed to assess the safety, tolerability and efficacy of brexpiprazole (Rexulti/Rxulti) in the treatment of patients with agitation in Alzheimer's dementia. It consists of a continuous 12-week double-blind treatment period with a 30-day follow-up.

A total of 330 patients aged 55-90 years, with a diagnosis of probable Alzheimer's disease, will be enrolled.

The decision to continue the trial is based on the results of an independent interim analysis.

Brexpiprazole was discovered by Otsuka and is being co-developed by Otsuka and Lundbeck. It is already approved as an adjunctive therapy for the treatment of adults with major depressive disorder and as a treatment for adults with schizophrenia in markets including the United States and Canada. In Europe and Japan, the product is approved for schizophrenia.

The trial is expected to be completed in the first half of 2022.



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