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Home Industry News Otsuka and Lundbeck commence bipolar therapy trial

Otsuka and Lundbeck commence bipolar therapy trial

12th October 2017

Otsuka and Lundbeck have commenced two phase III clinical trials to assess the safety and efficacy of a new treatment for bipolar I disorder.

Patient enrolment for the two global studies has begun, with the aim being to evaluate the drug brexpiprazole in the treatment of patients with manic episodes associated with the disorder.

The companies will recruit patients with bipolar I disorder who are experiencing acute manic episodes, with or without mixed features, that require hospitalisation. The term "mixed features" indicates that at least three symptoms of depression accompany manic episodes.

The primary endpoint of the trial will be to see whether brexpiprazole can deliver improvements in mania symptoms compared to placebo, while the key secondary endpoint will be reductions in the severity of illness.

It is hoped that these studies will add to the body of clinical evidence supporting the safety and efficacy of brexpiprazole, which was approved by the US Food and Drug Administration in July 2015 for the treatment of schizophrenia and major depressive disorder.

Subsequent approvals for schizophrenia followed in Canada and Australia earlier this year, with the drug being marketed in all three countries under the brand name Rexulti.

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