The Food and Drug Administration has accepted for review the New Drug Application (NDA) for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia.
The NDA submission includes data from two phase 3 studies (RISE; ClinicalTrials.gov Identifier: NCT03503318 and SHINE; ClinicalTrials.gov Identifier: NCT03893825), which evaluated the efficacy, safety, and tolerability of TV-46000 in adult and adolescent patients with schizophrenia.
In the RISE study, 544 patients aged 13 to 65 years were randomly assigned to receive TV-46000 once monthly (n=183), once every 2 months (n=179), or placebo (n=181). The primary endpoint was time to impending relapse.
Results showed that patients treated with the investigational subcutaneous risperidone injection experienced a statistically significant delay in the time to relapse compared with placebo (P <.0001). The risk of relapse was reduced by 80.0% and 62.5% in the once monthly and every 2 month groups, respectively, vs placebo. The safety profile of the investigational product was found to be consistent with that of other risperidone formulations.
The ongoing SHINE study is evaluating the long-term safety of TV-46000 in 331 patients for up to 56 weeks. According to Teva, findings from the trial thus far are aligning with those observed in the RISE study.
Long-acting formulations of risperidone that are currently FDA-approved for use in schizophrenia include Perseris (Indivior), which is administered once monthly by subcutaneous injection and Risperdal Consta (Janssen), an intramuscular formulation administered every 2 weeks.
- Teva and MedinCell announce FDA acceptance of New Drug Application for TV-46000/mdc-IRM as a treatment for patients with schizophrenia. News release. August 31, 2021. https://www.businesswire.com/news/home/20210831005107/en/Teva-and-MedinCell-Announce-FDA-Acceptance-of-New-Drug-Application-for-TV-46000mdc-IRM-as-a-Treatment-for-Patients-with-Schizophrenia.
- Teva and MedinCell announce positive results for registration trial of investigational extended-release subcutaneous injectable risperidone for patients with schizophrenia. News release. January 7, 2021. https://www.businesswire.com/news/home/20210107005533/en/Teva-and-MedinCell-Announce-Positive-Results-for-Registration-Trial-of-Investigational-Extended-Release-Subcutaneous-Injectable-Risperidone-for-Patients-with-Schizophrenia.