Johnson & Johnson announced that its investigational drug, CAPLYTA (lumateperone), demonstrated a reduction in the signs and symptoms of acute manic episodes associated with Bipolar I Disorder in a Phase 3 clinical trial.
The company disclosed that the data was presented at the 2024 Annual Meeting of the American Psychiatric Association. The trial evaluated CAPLYTA as monotherapy and in combination with lithium or valproate.
According to the results, CAPLYTA met its primary endpoint, showing statistically significant improvement in the Young Mania Rating Scale (YMRS) total score compared to placebo. The drug also demonstrated efficacy in reducing symptoms across multiple secondary endpoints.
Johnson & Johnson noted that the safety profile observed in the trial was consistent with previous studies of CAPLYTA.
