The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Intra-Cellular Therapies, Inc.’s lumateperone for the treatment of schizophrenia.  The action was requested based on clinical evidence that the drug has the potential to successfully treat schizophrenia along with with significant improvements on several safety issues, including metabolic, motor and cardiovascular conflicts associated with many current antipsychotic agents.  

The FDA’s Fast Track designation is designed to facilitate the development and expedite the review of drug candidates to treat serious and life-threatening conditions. Drug candidates with the designation may also qualify for priority review to expedite the FDA review process, if relevant criteria are met.

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