FDA Approves Lumateperone Indication for Major Depressive Disorder
The US Food and Drug Administration (FDA) has approved lumateperone (CAPLYTA®) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults, announced manufacturer Johnson & Johnson.
The November 6 approval comes after positive results from 2 Phase 3 global, double-blind, placebo-controlled trials, Study 501 and 502, which saw statistically significant improvement in depression symptoms compared to an oral antidepressant plus placebo.
Findings demonstrated a large separation in total Montgomery–Åsberg Depression Rating Scale (MADRS) score between lumateperone and placebo in Study 501 (-4.9 points, effect size 0.61) and Study 502 (-4.5 points, effect size 0.56) at 6 weeks. Both trials also saw significant reductions in the key secondary endpoint of mean change in total Clinical Global Impression Scale-Severity index (CGI-S) scores from baseline at week 6, with a difference of -0.7 points in Study 501 and -0.5 points in Study 502.
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Adverse effects, including weight gain, metabolic changes (lipid and glucose levels), akathisia, and restlessness, were similar to placebo, and reports of sexual side effects were not common.
“Major depressive disorder affects millions of Americans, impacting how a person feels, thinks, and acts,” said Michael Pollock, CEO of Depression and Bipolar Support Alliance (DBSA), in a news release. “…The introduction of new treatment options, and continued innovation in mental health, has enabled us to reset expectations for living with depression and offers people hope that achieving lasting wellness and remission is possible.”
The decision marks the fourth indication of lumateperone, which is also approved as an adjunctive and monotherapy for bipolar I and II depression in adults, and for the treatment of schizophrenia in adults.
The safety profile of lumateperone was consistent with existing clinical data for its previous indications. Common side effects include sleepiness, dizziness, nausea, dry mouth, feeling tired, and diarrhea. The drug also carries a boxed warning for increased mortality in elderly patients with dementia-related psychosis and a risk for suicidal thoughts and behaviors in young adult and pediatric patients.
