Posted by Michael Wonder on 24 Dec 2019
FDA approves Intra-Cellular Therapies’ novel anti-psychotic, Caplyta (lumateperone) for the treatment of schizophrenia in adults
23 December 2019 - Intra-Cellular Therapies today announced that Caplyta (lumateperone) has been approved by the U.S. FDA for the treatment of schizophrenia in adults.
The Company expects to initiate the commercial launch of Caplyta in late Q1, 2020.
The efficacy of Caplyta 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant separation from placebo on the primary endpoint, the Positive and Negative Syndrome Scale (PANSS) total score.
