Intra-Cellular Therapies Seeks FDA Approval for Caplyta as Adjunctive MDD Treatment
Key Insights
Intra-Cellular Therapies has submitted an sNDA to the FDA for Caplyta (lumateperone) as an adjunctive treatment for major depressive disorder (search) (MDD (search)).
The sNDA is supported by positive Phase 3 results, demonstrating significant antidepressant efficacy and a favorable safety profile for Caplyta.
If approved, Caplyta would address a critical need for effective and well-tolerated medicines for the millions of adults with MDD (search) who do not adequately respond to antidepressants alone.
Intra-Cellular Therapies, Inc. has announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Caplyta (lumateperone) for the treatment of major depressive disorder (search) (MDD (search)) in adults as an adjunctive therapy to antidepressants. The submission is based on data from two Phase 3 clinical trials, Studies 501 and 502, which demonstrated the drug's efficacy and safety in treating MDD patients with inadequate response to ongoing antidepressant therapy.
Dr. Suresh Durgam, Executive Vice President and Chief Medical Officer of Intra-Cellular Therapies, stated, "MDD (search) 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."
Clinical Trial Data
Studies 501 and 502 were global, double-blind, placebo-controlled trials that enrolled patients with a primary diagnosis of MDD (search) according to DSM-5 criteria who had an inadequate response to antidepressant therapy. The key findings from these studies include:
- Efficacy: Caplyta, when added to an antidepressant, showed significant efficacy in treating MDD, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. Study 501 showed a 4.9-point separation versus placebo (effect size 0.61), and Study 502 showed a 4.5-point separation (effect size 0.56).
- Safety and Tolerability: Caplyta demonstrated a favorable safety profile, including a favorable metabolic, weight, and movement disorder profile. Common adverse events (≥5% and twice the rate of placebo) included dizziness, dry mouth, somnolence/sedation, nausea, and fatigue. Metabolic and weight changes were similar to placebo, and rates of extrapyramidal symptoms were low.
Addressing Unmet Needs in MDD Treatment
Major Depressive Disorder (search) affects an estimated 21 million adults in the U.S. and is a leading cause of disability worldwide. Many patients do not achieve remission with first-line antidepressant treatments, highlighting the need for new therapeutic options. If approved, Caplyta could provide a valuable adjunctive treatment for those who do not respond adequately to antidepressants alone.
About Caplyta (lumateperone)
Caplyta is an oral, once-daily atypical antipsychotic currently approved for the treatment of schizophrenia (search) and depressive episodes associated with bipolar I or II disorder (bipolar depression (search)) as monotherapy or as adjunctive therapy with lithium or valproate. The mechanism of action of Caplyta is not fully understood but is believed to be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors (search) and postsynaptic antagonist activity at central dopamine D2 receptors (search).
Future Implications
Pending FDA approval, Caplyta could become a first-choice adjunctive treatment for MDD (search), potentially impacting over 30 million adult patients in the U.S. across three major psychiatric indications. The FDA's decision is eagerly anticipated by both the medical community and the millions of individuals affected by MDD.