Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and MedinCell announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.
Teva and Medincell remain committed to the development of risperidone and to providing patients with access to the product in the U.S., as quickly as possible. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations.
The application included Phase 3 data from two pivotal studies: TV46000-CNS-30072 (the RISE Study – The Risperidone Subcutaneous Extended-Release Study) and TV46000-CNS-30078 (the SHINE Study – A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia). These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia.