Johnson & Johnson reports positive CAPLYTA bipolar mania trial results

• Johnson & Johnson (NYSE:JNJ) reported positive Phase 3 results for CAPLYTA (lumateperone) in adults with bipolar I disorder experiencing acute manic episodes.
• CAPLYTA achieved a statistically significant improvement in mania symptoms compared with placebo.
• A second Phase 3 mania study has completed enrollment, with data analysis ongoing.

Johnson & Johnson (NYSE:JNJ) announced positive topline results from a pivotal Phase 3 trial evaluating CAPLYTA® (lumateperone) 42 mg once daily for the treatment of acute manic episodes in adults with bipolar I disorder.

In the randomized, double-blind Study 451, CAPLYTA demonstrated a statistically significant reduction in Young Mania Rating Scale (YMRS) total scores compared with placebo after three weeks of treatment.

Patients receiving CAPLYTA achieved a 4.8-point greater reduction in YMRS total score versus placebo at Week 3, with an effect size of −0.69 and a p-value below 0.0001.

Improvements were observed as early as Day 3 and continued through the end of the three-week treatment period.

The study also showed greater improvement in overall illness severity measured by the Clinical Global Impression–Severity scale, with a least-squares mean difference of −0.5 compared with placebo.

Patients treated with CAPLYTA achieved approximately double the clinical response rate compared with placebo, with 45.8% of patients achieving at least a 50% reduction in YMRS scores compared with 20.9% for placebo.

The safety and tolerability profile observed in the study was consistent with CAPLYTA’s established safety profile.

Treatment-related adverse events occurring at rates of at least 5% and at least twice the placebo rate included dry mouth and nausea.

CAPLYTA is currently not approved for treating manic episodes associated with bipolar I disorder. Johnson & Johnson said a second Phase 3 study evaluating CAPLYTA in bipolar mania has completed enrollment, with results under analysis.