Shots:
- The US FDA has received sNDA of Caplyta (lumateperone) for the prevention of relapse in schizophrenia; sNDA of Caplyta as an adjunctive therapy for MDD is under FDA’s review
- sNDA was supported by withdrawal P-III (Study 304) trial assessing Caplyta (42mg, QD) for 18wk. open-label phase followed by a double-blind phase, where pts received either Caplyta (n=114) or PBO (n=114) for 26wk. or until the time to relapse occurred
- Trial showed Caplyta prolonged time to relapse (1EP) vs PBO over 26wks. & reduced relapse risk by 63% as well as showed significant delay in time to all-cause discontinuation (2EP), incl. relapse, during 26wks.
Ref: J&J| Image: J&J | Press Release
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