Shots:
- The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted
- Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts
- Trial showed improved MADRS scores (1EP) in Study 501 (-4.9; effect size 0.61) & Study 502 (-4.5; 0.56) at 6wks., with separation from PBO by Wk. 1 & 2, respectively; CGI-S (2EP) also improved (-0.7; 0.67 & -0.5; 0.51). In a 26wk. safety study, 80% treated pts responded & 65% achieved remission (MADRS ≤10)
Ref: Johnson & Johnson | Image: Johnson & Johnson | Press Release
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