Key facts
- The trial tested a 42 mg daily dose of Caplyta against placebo over three weeks in adults with manic episodes.
- Mania scores in patients taking Caplyta dropped 3.7 points more than placebo, J&J said, with improvement seen as early as day three.
- Nearly 44% of Caplyta patients had at least a 50% improvement in mania symptoms, against about 24% on placebo, per J&J.
- J&J said the two late-stage studies together will support a planned submission to the US Food and Drug Administration for bipolar mania.
- Caplyta is already approved in the US for bipolar depression, schizophrenia and certain cases of major depression.
- J&J gained Caplyta through its $14.6 billion acquisition of Intra-Cellular Therapies last year.
Johnson & Johnson said on November 10 that Caplyta eased manic symptoms better than placebo in a second late-stage study of adults with bipolar I disorder, a result the company said will support a planned submission to the US Food and Drug Administration seeking approval for bipolar mania.
The trial tested a 42 mg daily dose of Caplyta against placebo over three weeks in adults with manic episodes, with or without mixed features, associated with bipolar I disorder. Mania scores in patients taking the drug dropped 3.7 points more than those on placebo, J&J said, based on a standard rating scale, with improvement seen as early as day three.
Nearly 44% of patients treated with Caplyta had at least a 50% improvement in mania symptoms, compared with about 24% on placebo, according to the company. The results follow positive findings from the first late-stage study of the drug for mania.
Caplyta is already approved in the US for bipolar depression, schizophrenia and certain cases of major depression. J&J gained access to the drug through its $14.6 billion acquisition of Intra-Cellular Therapies last year to bolster its neuroscience business.
UBS analysts had said in a September note that Caplyta could reach long-term peak sales above $5 billion, though they expect sales of about $4.3 billion by 2033. Bipolar disorder affects an estimated 36 million people worldwide, according to the report.