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Johnson & Johnson announced that its drug Caplyta (lumateperone) demonstrated a statistically significant and rapid reduction in manic symptoms at Week 3 in a pivotal Phase 3 study for bipolar mania. The drug was well-tolerated, with dry mouth and nausea being the most common adverse events.
Caplyta Demonstrates Statistically Significant Rapid Reduction In Manic Symptoms At Week 3 Caplyta Well-Tolerated; Dry Mouth And Nausea Most Common Adverse Events
Johnson & Johnson reported positive topline Phase 3 results for Caplyta in acute manic episodes tied to bipolar I disorder. The trial showed rapid, sustained symptom improvement versus placebo, supporting a potential expansion beyond bipolar depression and schizophrenia.