Johnson & Johnson says Caplyta improved bipolar mania in second pivotal Phase 3 study
JNJ•Johnson & Johnson said Caplyta significantly improved manic symptoms and illness severity at week three in a second pivotal Phase 3 study. At least 50% YMRS improvement occurred in 43.9% of patients taking Caplyta, versus 23.7% on placebo.
1. Phase 3 results
Caplyta met a key secondary endpoint, with greater CGI-S improvement at week three. Johnson & Johnson said the treatment was well tolerated with low discontinuation; common adverse events included dizziness, dry mouth and somnolence. The company said two Phase 3 studies will support a planned FDA submission for bipolar mania.
