Johnson & Johnson Submits sNDA To FDA For Oral Caplyta® As Schizophrenia Relapse Prevention

Johnson & Johnson submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of Caplyta® (lumateperone), an oral medication to prevent schizophrenia relapse. The sNDA is supported by results from a clinical trial that tested Caplyta as relapse prevention and found a 63% reduction in risk of relapse compared to a placebo.;;

Caplyta® is the newest addition to Johnson & Johnson’s portfolio of schizophrenia therapies, which offers a range of oral and long-acting injectable treatment options to support each person . . .