Johnson & Johnson announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) based on long-term data evaluating the safety and efficacy of CAPLYTA (lumateperone) for the prevention of relapse in schizophrenia. The data further reinforces the long-term efficacy and tolerability of CAPLYTA as the latest addition to Johnson & Johnson's leading portfolio of neuropsychiatric therapies.

In the phase 3, double-blind, randomised withdrawal trial supporting this update, CAPLYTA significantly extended time to relapse versus placebo during the 26-week double-blind treatment period (p=0.0002), helping support long-term stability for adults living with schizophrenia. Patients who received CAPLYTA had a 63 percent lower risk of relapse compared with placebo (hazard ratio = 0.37), and 84 percent of patients were relapse-free over six months. CAPLYTA also significantly delayed time to all-cause treatment discontinuation, including relapse. The safety profile remained consistent with the existing body of clinical data, and no new safety concerns were identified. The most common treatment-related adverse event was headache, which occurred in at least five percent of patients and at least twice the rate of placebo.

Christoph U. Correll, M.D., Clinical Professor of Psychiatry at the Zucker School of Medicine at Hofstra/Northwell, New York, said, “Relapse can be one of the most disruptive aspects of schizophrenia, often undoing hard-won progress and increasing the risk of hospitalisation. These phase 3 results—showing significantly longer time to relapse with 84 percent remaining relapse free over six-months—provide clinicians with another tool that can offer long-term stability for people living with schizophrenia."

While its exact mechanism of action is unknown, CAPLYTA is characterised by high serotonin 5-HT2A receptor occupancy and moderate amounts of dopamine D2 receptor occupancy at therapeutic doses. In schizophrenia short-term clinical studies, CAPLYTA was similar to placebo in weight change, metabolic effects, and extrapyramidal symptoms, which are often cited as reasons for treatment discontinuation. 

In the phase 3, six-month randomised withdrawal, double-blind, placebo-controlled study, there were no clinically relevant increases in prolactin or cardiometabolic parameters at the end of the double-blind treatment period. Additionally, long-term data from a 12-month open-label extension study in schizophrenia showed that patients treated with CAPLYTA experienced a mean weight change of –2.05 kg (–4.52 lbs.) over one year, with sustained improvements or stability in metabolic parameters. CAPLYTA makes it easy to start and stay on treatment without the need for titration.

Celine Goldberger, M.D, P.hD, Vice President, Global Medical Affairs, Neuroscience, Innovative Medicine, Johnson & Johnson, said, "People living with schizophrenia deserve treatment options that help support stability over time, not just symptom control in the short term. This label update—backed by long-term phase 3 data demonstrating a significant delay in time to relapse—reinforces our commitment to advancing evidence-based therapies to support each patient's individual needs including a proven therapy that supports stability over time."

CAPLYTA (lumateperone) is FDA-approved in adults as an adjunctive therapy with antidepressants for Major Depressive Disorder (MDD), schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression), as monotherapy, and as adjunctive therapy with lithium or valproate. This label update builds upon the existing clinical data and postmarketing experience across its approved uses. CAPLYTA is also being evaluated in clinical studies for other neuropsychiatric and neurological conditions beyond its current FDA-approved indications.