Admin_Adham
The FDA has approved a supplemental new drug application for lumateperone (Caplyta, Johnson & Johnson) for the prevention of relapse in adults with schizophrenia.
The label expansion was based on phase 3 data demonstrating that treatment with the oral, once daily atypical antipsychotic significantly extended time to relapse (vs placebo) during the 26-week double-blind treatment period (P = .0002), the company said in a news release.
Patients who received lumateperone (42 mg/day) had a 63% lower relapse risk compared with placebo (hazard ratio, 0.37), with 84% relapse-free over 6 months. Lumateperone also significantly delayed time to all-cause treatment discontinuation, including relapse.
The safety profile was in line with the existing body of clinical data, with no new safety issues. The most common treatment-related adverse event was headache, which occurred in at least 5% of patients and at least twice the rate of placebo.
“Relapse can be one of the most disruptive aspects of schizophrenia, often undoing hard-won progress and increasing the risk of hospitalization,” Christoph U. Correll, MD, professor of psychiatry, Zucker School of Medicine at Hofstra/Northwell, New York, said in the release.
“These phase 3 results — showing significantly longer time to relapse with 84% remaining relapse free over 6 months — provide clinicians with another tool that can offer long-term stability for people living with schizophrenia,” Correll added.
Lumateperone is approved in the US for adults as an adjunctive therapy with antidepressants for major depressive disorder, schizophrenia, and depressive episodes associated with bipolar I or II disorder (bipolar depression) — both as monotherapy and as adjunctive therapy with lithium or valproate.
