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FDA grants fast track designation to lumateperone for schizophrenia

Intra-Cellular Therapies Inc. recently announced the FDA granted fast track designation for lumateperone for treatment of schizophrenia.

Lumateperone is a dopamine receptor phosphoprotein modulation that provides selective and simultaneous modulation of serotonin, dopamine and glutamate.

Safety and efficacy of lumateperone were evaluated in three randomized, double-blind, placebo-controlled studies.

In two studies, lumateperone was statistically significantly separate from placebo at the primary endpoint, Positive and Negative Syndrome Scale total score.

Lumateperone was well-tolerated and had a similar safety profile to placebo in all three studies.

“We are pleased with the FDA’s designation of lumateperone for Fast Track development,” Sharon Mates, PhD, chairman and CEO of Intra-Cellular Therapies, said in a press release. “Given the important safety and tolerability limitations of existing antipsychotics, we believe that lumateperone may represent a significant advance in the treatment of schizophrenia.”