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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