Johnson & Johnson said its antipsychotic Caplyta significantly reduced manic symptoms in adults with bipolar I disorder in a pivotal Phase 3 trial, though the medicine is not approved for treating manic episodes.
The randomized, double-blind Study 451 compared once-daily 42-milligram Caplyta, or lumateperone, with placebo over three weeks in adults experiencing manic episodes with or without mixed features associated with bipolar I disorder.
Caplyta met the trial’s primary endpoint, producing a 4.8-point greater reduction from baseline in Young Mania Rating Scale total score than placebo at Week 3. The difference corresponded to an effect size of negative 0.69 and was statistically significant, with a p-value below 0.0001. Johnson & Johnson said a significant difference was observed by Day 3 and sustained through Week 3.
Patients receiving Caplyta also showed greater improvement in overall illness severity on the Clinical Global Impression-Severity scale, a key secondary endpoint. The least-squares mean difference versus placebo was negative 0.5 at Week 3, with a p-value below 0.0001.
Clinical response, defined as at least a 50% reduction in Young Mania Rating Scale score, was reported in 45.8% of Caplyta-treated patients, compared with 20.9% of placebo-treated patients.
The most common treatment-related adverse events occurring in at least 5% of Caplyta patients and at least twice the placebo rate were dry mouth, reported by 7.9% of Caplyta patients versus 3.4% of placebo patients, and nausea, reported by 7.9% versus 2.3%.
Caplyta is currently approved for schizophrenia; depressive episodes associated with bipolar I or bipolar II disorder, alone or with lithium or valproate; and as an adjunct to antidepressants for major depressive disorder in adults. Johnson & Johnson said a second pivotal Phase 3 study, Study 452, has been completed and is under analysis.
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