The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Teva and MedinCell regarding the New Drug Application for TV-46000/mdc-IRM (risperidone extended-release injectable suspension for subcutaneous use) for the treatment of schizophrenia. The CRL states that the application cannot be approved in its current form and requires the Companies to address certain deficiencies prior to resubmission.
The investigational subcutaneous risperidone injection product was evaluated in two phase 3 studies (RISE; ClinicalTrials.gov Identifier: NCT03503318 and SHINE; ClinicalTrials.gov Identifier: NCT03893825).
Results from the RISE study showed treatment with TV-46000/mdc-IRM (once monthly or every 2 months) was associated with a statistically significant delay in the time to relapse compared with placebo (P <.0001). No new safety signals were reported during the trial.
According to Teva, findings from the SHINE study, which evaluated long-term safety for maintenance treatment, aligned with those observed in the RISE study.
Christophe Douat, CEO of MedinCell, said: “We fully trust that our partner, Teva, will remedy this quickly given the positive results of the phase 3 studies.”
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 receive Complete Response Letter for TV-46000/mdc-IRM. News release. Accessed April 20, 2022. https://www.businesswire.com/news/home/20220419006090/en/Teva-and-MedinCell-Receive-Complete-Response-Letter-for-TV-46000mdc-IRM
- MedinCell provides additional information regarding the new drug application for mdc-IRM. News release. Accessed April 20, 2022. https://www.medincell.com/en/2022/04/20/medincell-provides-additional-information-regarding-the-new-drug-application-for-mdc-irm/