Johnson & Johnson said Caplyta met the primary endpoint in a Phase 3 study of adults experiencing manic episodes associated with bipolar I disorder. The once-daily 42-milligram treatment produced a statistically significant 4.8-point greater reduction in Young Mania Rating Scale scores than placebo at Week 3, with improvement emerging as early as Day 3. Caplyta also improved overall illness severity, while 45.8% of treated patients achieved a clinical response versus 20.9% of placebo recipients. The treatment showed favorable tolerability and low discontinuation rates. A second pivotal Phase 3 study has been completed, with analysis underway. Caplyta is already approved in the United States for depressive episodes associated with bipolar I and bipolar II disorder, as well as schizophrenia, following J&J's $14.6 billion acquisition of Intra-Cellular Therapies last year.