Dec. 23, 2019 : U.S. Food and Drug Administration(FDA) approved Intra-Cellular Therapie’s CAPLYTA® (lumateperone) for the treatment of schizophrenia in adults, commercial launch of CAPLYTA in late Q1 2020.
The efficacy of CAPLYTA 42mg was established in two placebo-controlled trials, showing a statistically noteworthy separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score.
The general adverse reactions (≥5% and twice the rate of placebo) for the suggested dose of CAPLYTA vs placebo were somnolence/sedation (24% vs.10%) and dry mouth (6% vs. 2%).
https://fda.einnews.com/pr_news/505579239/fda-approves-intra-cellular-therapies-novel-antipsychotic-caplyta-lumateperone-for-the-treatment-of-schizophrenia-in-adults
