sNDA Submitted: Lumateperone as Adjunctive Therapy for Major Depressive Disorder

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Intra-Cellular Therapies announced they recently submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (FDA) for lumateperone (Caplyta) for the treatment of major depressive disorder (MDD) in adults as adjunctive therapy to antidepressants.^1,2

“MDD is a highly prevalent condition with a significant need for efficacious, safe, and well-tolerated medicines, as more than half of patients do not adequately respond to an antidepressant alone,” said Suresh Durgam, MD, executive vice president and chief medical officer of Intra-Cellular Therapies. “Given Caplyta’s efficacy and safety profile, we believe Caplyta can become a first-choice treatment for the adjunctive treatment of MDD pending FDA approval, and we look forward to working with the FDA during this review process.”

The studies forming the basis of the sNDA, studies 501 and 502, are 2 positive phase 3 global, double-blind, placebo-controlled studies in participants with a primary diagnosis of MDD, as per DSM-5 criteria, who have had an inadequate response to antidepressants.

Caplyta, added to antidepressant treatment, demonstrated robust efficacy for MDD in the primary endpoint, the Montgomery Asberg Depression Rating Scale (MADRS) total score, with a large separation vs placebo of 4.9 points (effect size 0.61) in study 501 and 4.5 points (effect size 0.56) vs placebo in study 502.

Caplyta also demonstrated a favorable safety and tolerability profile, including a favorable metabolic, weight, and movement disorder profile. The most commonly reported adverse events in the pooled safety data for studies 501 and 502 that were observed at a rate greater than or equal to 5% for lumateperone and greater than twice the rate of placebo were dizziness, dry mouth, somnolence/sedation, nausea, and fatigue. Metabolic and weight changes were similar to placebo. Rates of extrapyramidal symptoms were low.

“MDD is the leading cause of disability in the world, where about two-thirds of patients fail to achieve remission with first-line treatment,” said Durgam previously.³ “In both pivotal registrational studies, study 501 and study 502, lumateperone demonstrated a robust effect as an adjunctive treatment to antidepressants in patients with MDD who had inadequate response to antidepressant therapy. The consistent efficacy, safety and tolerability profile of lumateperone has the potential to be a compelling treatment option for MDD.”

You can read more about study 502 here.

References

1. Intra-Cellular Therapies submits supplemental new drug application (sNDA) to FDA for CAPLYTA® (lumateperone) for the treatment of major depressive disorder as adjunctive therapy. News release. December 3, 2024. Accessed December 3, 2024. https://ir.intracellulartherapies.com/news-releases/news-release-details/intra-cellular-therapies-submits-supplemental-new-drug

2. Armstrong A. Intra-Cellular eyes depression approval for Caplyta as stock flies under the radar. BioSpace. December 3, 2024. Accessed December 3, 2024. https://www.biospace.com/business/intra-cellular-eyes-depression-approval-for-caplyta-as-stock-soars-under-the-radar

3. Kuntz L. Lumateperone as an adjunctive therapy to antidepressants: more positive results. Psychiatric Times. June 18, 2024. https://www.psychiatrictimes.com/view/lumateperone-as-an-adjunctive-therapy-to-antidepressants-more-positive-results