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Caplyta improved manic symptoms and overall illness severity compared with placebo in a second Phase 3 study, Johnson & Johnson said Tuesday. The company said the trial met its primary and key secondary endpoints in adults with bipolar I disorder experiencing manic episodes, with or without mixed features.
The differences were significant at week three, and improvements were observed as early as day three, J&J said. The New Brunswick, N.J.-based drugmaker reported positive results from a separate Phase 3 study in September.
J&J said the latest findings will support a planned application to the U.S. Food and Drug Administration to expand Caplyta’s approval to include bipolar mania. The condition affects around 36 million people worldwide, according to the company.
Caplyta is already approved for depressive episodes associated with bipolar I or II disorder, schizophrenia and major depressive disorder. It was a key asset in J&J’s $14.6 billion acquisition of Intra-Cellular Therapies last year.
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