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Intra-Cellular Therapies Reports Results From Study 304 Evaluating Lumateperone 42 Mg For The Prevention Of Relapse In Adult Patients With Schizophrenia; Says Study Showed Efficacy Along With Favorable Safety And Tolerability
Intra-Cellular Therapies, Inc. ITCI | 131.87 131.87 | Delist 0.00% Post |
On the primary endpoint, time to relapse during the double-blind treatment phase was significantly longer in patients receiving lumateperone compared to those receiving placebo (p=0.0002). There were 18 relapses (16.4%) in the lumateperone group versus 44 relapses (38.6%) in the placebo group. Treatment with lumateperone was associated with a 63% reduction in risk of relapse versus placebo (hazard ratio [95% CI] = 0.37, [0.22, 0.65]).
Lumateperone also met the key secondary endpoint, time to all cause discontinuation during the double-blind phase (p=0.0007).


