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Teva Pharmaceutical and MedinCell, the drug’s developers, didn’t provide a reason for the complete response letter.
The 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. The FDA had accepted the application in August 2021 for TV-46000, which was developed by Teva Pharmaceutical and MedinCell.
The companies didn’t provide a reason for the CRL.
The regulatory application included phase 3 data from two pivotal studies: the RISE study and the SHINE. These studies evaluated the efficacy and long-term safety and tolerability of TV-46000 as a treatment for patients with schizophrenia. Data from the RISE study found that TV-46000 decreased the risk of relapse and increased chance of clinical stability versus placebo in patients with schizophrenia. The safety profile is consistent with other formulations of risperidone and included nasopharyngitis, increased weight, and movement disorder.
Schizophrenia is a chronic and severe mental disorder characterized by distortions in thinking, perception, emotions, language, sense of self and behavior. Twenty million people worldwide are affected by schizophrenia.