Johnson & Johnson — Caplyta FDA Review (NDA209500, SUPPL 6, 2021)
Johnson & Johnson · 2021 · FDA Review (openFDA) · company profile →
Report summary
The FDA approved Caplyta (lumateperone) for treating depressive episodes in adults with bipolar I or II disorder, both as monotherapy and adjunctive therapy. This approval was based on efficacy demonstrated in Studies 402 and 404, where the 42 mg dose significantly improved MADRS total scores, though Study 401-A was negative. The safety profile, consistent with schizophrenia trials, showed common adverse reactions like somnolence and dry mouth, with low rates of extrapyramidal symptoms and minimal metabolic changes. Warnings include increased mortality in elderly dementia patients and suicidal thoughts in pediatric/young adult patients. Postmarketing requirements include pediatric studies. The review also covered pharmacokinetics, nonclinical toxicology, and financial disclosures.
Key findings — cited to the page
| Incidence of irritability leading to discontinuation (OLE Study 401-B, lumateperone 42-mg) | 3 patients | Study 401-B · p.133 |
| Recommended Dosage | 42 mg once daily | Caplyta · p.200 |
| Postmarketing requirement 4192-1: GLP juvenile animal study final report submission | 02/2022 | Caplyta (lumateperone) · US · p.6 |
| 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 |
| Enrolment N | 528 subjects | ITI-007-402 · p.187 |
| Pediatric deferral for Caplyta | deferred for ages 10 to 17 years | Caplyta (lumateperone) · US · p.5 |
| NDA approval for Caplyta | approved | Caplyta (lumateperone) · US · p.4 |
| Postmarketing requirement 4192-2: Open-label safety, tolerability, and PK study in 10-17 years old with bipolar depression - Final Protocol Submission | 05/2022 | Caplyta (lumateperone) · US · p.6 |
| New indication for Caplyta | depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate | Caplyta (lumateperone) · US · p.4 |
| Proposed Indication | Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy | Caplyta · p.200 |
| Pediatric waiver for Caplyta | waived for ages 0 to 9 years | Caplyta (lumateperone) · US · p.5 |
| Strength | 42 mg | Caplyta · p.200 |
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 →