Shots:
- J&J has reported the P-III (Study 451) trial data, assessing Caplyta (lumateperone; 42mg, QD) vs PBO for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder, at Psych Congress 2026
- Trial met its 1EP, showing a 4.8-point greater reduction in YMRS total score at Wk. 3, with benefit seen as early as day 3, plus demonstrated improvement in overall illness severity, measured by the CGI-S score (2EP). 45.8% vs 20.9% pts achieved a ≥50% reduction in YMRS total score
- Caplyta was also assessed in the P-III (Study 452) for the treatment of manic episodes in adults with bipolar I disorder, with data analysis underway
Ref: PRnewswire | Image: J&J | Press Release
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