DAYBREAK phase III study for Lu AF35700 fails to meet endpoint in schizophrenia.- Lundbeck.
Lundbeck announced that DAYBREAK, the first phase III study for Lu AF35700, an investigational, novel, once-daily, oral antipsychotic drug candidate for the potential treatment of treatment-resistant schizophrenia (TRS), did not meet the primary endpoint of statistical superiority vs conventional therapy. Lu AF35700 was safe and generally well-tolerated in the study with no unexpected adverse events reported.
DAYBREAK was a multinational, double-blind, randomized, active-controlled phase III study that evaluated the antipsychotic efficacy, safety and tolerability of Lu AF35700 compared to an active-controlled arm over ten weeks in 964 patients with TRS.
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