J&J's Caplyta hits main goal in late-stage bipolar mania trial

Johnson & Johnson said its experimental use of Caplyta for bipolar mania met the main goal of a late-stage study, moving the drug closer to an indication beyond its current approvals.

The company acquired Caplyta through its $14.6 billion purchase of Intra-Cellular Therapies last year, a deal aimed at strengthening its neuroscience portfolio.

In the trial, Caplyta significantly reduced symptoms of bipolar mania compared with placebo, satisfying the study's primary endpoint. Manic symptoms can include grandiosity, a reduced need for sleep, racing thoughts, distractibility and risk-taking behaviour.

Patients began showing improvement as early as three days after starting treatment, and the benefits held through the study's three-week duration, according to the company. The trial also met a key secondary goal measuring the overall severity of illness.

About 46% of patients who received Caplyta achieved a clinical response, compared with roughly 21% of those on placebo.

The study tested a once-daily 42-milligram dose in adults experiencing manic episodes linked to bipolar I disorder.

Caplyta is already approved in the United States for depressive episodes associated with bipolar I and bipolar II disorder, as well as for schizophrenia.

Bipolar disorder affects an estimated 37 million people worldwide. Mania, a defining feature of bipolar I disorder, is marked by unusually elevated or irritable mood and increased energy or activity, often occurring alongside depressive episodes.