Neurological

Long-acting schizophrenia treatment application accepted for consideration

Subjects ” Neurological behavior disorders

The Food and Drug Administration has accepted the NDA for TV-46000 / mdc-IRM (risperidone sustained release suspension for subcutaneous use) for the treatment of schizophrenia for review.

The NDA filing includes data from two Phase 3 studies (RISE; ClinicalTrials.gov Identifier: NCT03503318 and SHINE; ClinicalTrials.gov Identifier: NCT03893825) assessing the efficacy, safety, and tolerability of TV-46000 in adult and adolescent patients were rated with schizophrenia.

In the RISE study, 544 patients aged 13 to 65 were randomly assigned to TV-46000 once a month (n = 183), once every 2 months (n = 179), or placebo (n = 181). The primary endpoint was time to impending relapse.

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The results showed that there was a statistically significant delay in time to relapse in patients treated with the investigated subcutaneous risperidone injection compared to placebo (P <0.0001). The risk of relapse was reduced by 80.0% and 62.5% in the monthly and bi-monthly groups compared to placebo. The safety profile of the investigational medicinal product was found to be consistent with that of other risperidone formulations.

The ongoing SHINE study examines the long-term safety of TV-46000 in 331 patients over a period of up to 56 weeks. According to Teva, the results of the study so far are consistent with those of the RISE study.

Long-acting risperidone formulations currently FDA approved for use in schizophrenia include Perseris (Indivior), which is given by subcutaneous injection once a month, and Risperdal Consta (Janssen), an intramuscular formulation, which is given every 2 weeks is administered.

References

  1. Teva and MedinCell announce that the FDA has approved a new drug submission for TV-46000 / mdc-IRM for the treatment of patients with schizophrenia. Press 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.
  2. Teva and MedinCell announce positive results for the pivotal study of the investigational drug risperidone for extended-release subcutaneous injection for patients with schizophrenia. Press 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.

This article originally appeared on MPR

Subjects:

Neurological behavioral disorder schizophrenia

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