FDA Approves Caplyta (lumateperone) for Schizophrenia in Adults

Not reported in label.

CAPLYTA is indicated for treatment of schizophrenia in adults. The clinical studies included adult patients with a diagnosis of schizophrenia according to DSM-IV-TR or DSM-5 criteria. Studies 1 and 2 did not include any patients aged 65 or older.

The recommended dosage of CAPLYTA is 42 mg administered orally once daily with or without food. Dose titration is not needed. For patients receiving strong CYP3A4 inhibitors, the recommended dosage is 10.5 mg once daily; for moderate CYP3A4 inhibitors, 21 mg once daily. For patients with moderate hepatic impairment (Child-Pugh class B) or severe hepatic impairment (Child-Pugh class C), the recommended dosage is 21 mg once daily. Patients with mild hepatic impairment should receive the same dosage as those with normal hepatic function.

CAPLYTA was evaluated for schizophrenia in two placebo-controlled trials. Study 1 (NCT01499563) randomized 335 patients to CAPLYTA 42 mg, CAPLYTA 84 mg, active comparator, or placebo. The primary endpoint was change from baseline in PANSS total score at Week 4. CAPLYTA 42 mg showed statistically significant improvement vs placebo (LS mean difference -5.8, 95% CI -10.5, -1.1). The 84 mg dose did not show statistical significance. Study 2 (NCT02282761) randomized 450 patients to CAPLYTA 28 mg, CAPLYTA 42 mg, or placebo. CAPLYTA 42 mg showed statistically significant improvement vs placebo (LS mean difference -4.2, 95% CI -7.8, -0.6). The 28 mg dose did not show statistical significance. Examination of subgroups by sex and race did not suggest differences in response.

Not reported in label.

CAPLYTA is a new atypical antipsychotic approved for schizophrenia in adults. It offers a once-daily dosing without need for titration. Efficacy was demonstrated in two short-term trials. The drug is also approved for bipolar depression and as adjunctive therapy for MDD, which may be relevant for patients with comorbid conditions.