Johnson & Johnson — Caplyta FDA Review (NDA209500, SUPPL 5, 2021)
Johnson & Johnson · 2021 · FDA Review (openFDA) · company profile →
Report summary
The FDA approved Caplyta (lumateperone) on December 17, 2021, for treating depressive episodes in adults with bipolar I or II disorder, as both monotherapy and adjunctive therapy. Postmarketing pediatric studies are required, and warnings include increased mortality in elderly dementia patients and suicidal thoughts in pediatric/young adult patients. Caplyta's safety profile, consistent with its schizophrenia indication, shows common adverse reactions like somnolence and dry mouth. Efficacy for bipolar depression was demonstrated in Studies 402 and 404, where the 42 mg dose significantly improved MADRS total scores. Study 401-A, however, did not meet its primary endpoint. The 42 mg dose was confirmed appropriate, with detailed clinical pharmacology, regulatory background, and financial disclosures also reviewed.
Key findings — cited to the page
| irritability leading to discontinuation (lumateperone 42 mg, OLE Study 401-B) | 3 patients | · p.133 |
| percentage of irritability leading to discontinuation (lumateperone 42 mg, OLE Study 401-B) | 2.4 % | · p.133 |
| Dosage Form | Capsules | Caplyta · p.200 |
| Number of Patients Treated Part 2 | 602 | ITI-007-303 · p.71 |
| Proposed Indication | Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate | Caplyta · p.200 |
| Route of Administration | Oral | Caplyta · p.200 |
| Regimen/Schedule | Luma 42 mg | ITI-007-303 · p.71 |
| Trial Design | Open label | ITI-007-303 · p.71 |
| Treatment Duration Part 2 | 1 year | ITI-007-303 · p.71 |
| Number of Patients Treated Part 1 | 315 | ITI-007-303 · p.71 |
| Proposed Indication | Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy | Caplyta · p.200 |
| Treatment Duration Part 1 | 6 weeks | ITI-007-303 · p.71 |
Source: Johnson & Johnson ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →