Supplemental NDA submitted to FDA for Caplyta (lumateperone) for the treatment of Major Depressive Disorder

“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 Dr. Suresh Durgam, 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.”

Studies 501 and 502 are two positive Phase III global, double-blind, placebo-controlled studies in patients with a primary diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria who have had an inadequate response to ongoing anti-depressant therapy. These studies form the basis of the sNDA.

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

Caplyta's efficacy is complemented with a favorable safety and tolerability profile - including a favorable metabolic, weight and movement disorder profile. In the pooled safety data for Studies 501 and 502, the most commonly reported adverse events 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. Importantly, metabolic and weight changes were similar to placebo and the rates of extrapyramidal symptoms were low.