By Fineline Cube 
US giant Johnson & Johnson (J&J, NYSE: JNJ) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Caplyta (lumateperone), seeking approval for the prevention of schizophrenia relapse.
Drug Mechanism
While the exact mechanism of Caplyta remains unclear, it demonstrates high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy at therapeutic doses.
Current Approvals and Ongoing Reviews
Caplyta is currently approved in the US for treating schizophrenia in adults and for use as monotherapy or adjunctive therapy with lithium or valproate for depressive episodes associated with bipolar I or II disorder. An sNDA for Caplyta as an adjunctive treatment for major depressive disorder (MDD) in adults is also under FDA review.
Clinical Trial Data
The recent sNDA filing is supported by long-term data from a Phase III study. Results showed that during the 26-week double-blind treatment period, schizophrenia patients treated with Caplyta experienced significantly longer time to relapse compared to those receiving a placebo.-Fineline Info & Tech