Intra-Cellular Therapies Files sNDA for CAPLYTA® as Adjunctive Treatment for Major Depressive Disorder

Intra-Cellular Therapies, Inc., a biopharmaceutical company specializing in treatments for central nervous system disorders, has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for their drug CAPLYTA (lumateperone). This application aims to expand CAPLYTA's use to include treatment of Major Depressive Disorder (MDD) in adults, in conjunction with antidepressants.

Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer at Intra-Cellular Therapies, emphasized the necessity for effective treatments for MDD, noting that a significant number of patients do not respond adequately to antidepressants alone. Dr. Durgam highlighted CAPLYTA's strong efficacy and favorable safety profile, expressing confidence that it could become a preferred option for adjunctive MDD treatment pending FDA approval.

The sNDA submission is supported by the results from Studies 501 and 502, both Phase 3 clinical trials. These studies involved patients with a primary diagnosis of MDD according to DSM-5 criteria who had not sufficiently responded to their current antidepressant therapy. CAPLYTA, when added to an antidepressant regimen, showed notable improvements in depressive symptoms. Specifically, patients in Study 501 exhibited a 4.9-point improvement on the Montgomery Asberg Depression Rating Scale (MADRS) compared to placebo, while Study 502 showed a 4.5-point improvement on the same scale.

Beyond efficacy, CAPLYTA demonstrated a positive safety and tolerability profile. In the pooled analysis from Studies 501 and 502, common adverse events included dizziness, dry mouth, somnolence or sedation, nausea, and fatigue, occurring at rates higher than placebo. Importantly, metabolic and weight changes were similar to those observed with placebo, and incidents of movement disorders were low, underscoring CAPLYTA's favorable safety profile.

Major Depressive Disorder (MDD) is a widespread mental health condition, affecting approximately 21 million adults annually in the U.S. Symptoms of MDD include persistent sadness, lack of interest in enjoyable activities, cognitive impairments, and in severe cases, suicidal thoughts or behaviors. MDD can severely impact quality of life and interpersonal relationships, and it is estimated that two-thirds of patients do not achieve remission with first-line treatments alone.

CAPLYTA is already approved for treating schizophrenia and depressive episodes associated with bipolar I and II disorders as both monotherapy and as an adjunctive therapy with lithium or valproate. The drug's mechanism of action is believed to involve antagonism of central serotonin 5-HT2A receptors and dopamine D2 receptors, although the exact mechanisms remain unclear.

Intra-Cellular Therapies continues to explore lumateperone's potential in treating other psychiatric and neurological conditions, such as major depressive disorder. Founded on Nobel prize-winning research, the company focuses on developing innovative treatments for complex psychiatric and neurological diseases by understanding how therapies affect cellular processes.

CAPLYTA's potential approval for MDD as an adjunctive therapy could lead to its indication for three major psychiatric conditions, providing new hope for over 30 million adult patients in the US who suffer from these disorders.