J&J Gets USFDA Nod for Caplyta to Treat Major Depression

The Johnson & Johnson's (J&J) CAPLYTA (lumateperone) product has been given a green light by the U.S. Food and Drug Administration (USFDA) to be used as adjunctive therapy with antidepressants for adult major depressive disorder (MDD) treatment.

To date, this is the 4th FDA-approved indication of CAPLYTA. The drug is already approved for bipolar I and II depression both as adjunctive and monotherapy and schizophrenia in adults.

Major depressive disorder (MDD) is the cause of more than 22 million American adult lives and, thus, ranks among the primary reasons for the U.S. disabilities. The problem is that despite the existence of treatments, almost 66% of patients continue to experience residual symptoms.

One could say that CAPLYTA offers a simplified treatment approach- as it requires no dose titration- and also showed in clinical trials a safety profile similar to that of the placebo with regard to weight and metabolic effects.

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Johnson and Johnson’s FDA approval is based upon a pair of Phase 3 global studies (501 and 502) where CAPS resounded as the most significant improvement in depressive symptoms to the sham, with the earliest symptoms’ separation being evident within one to two weeks.

Study 503 long-term data, in the same vein, confirmed sustained efficacy and safety, with 80% of patients responding and 65% achieving remission at six months.

For Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, J&J Innovative Medicine, the approval is a testament to the company's commitment to mental health innovations, having CAPLYTA as a potential new standard of care for patients struggling with depression.