US FDA accepts Teva-MedinCell’s new drug application for drug to treat schizophrenia
US FDA accepts Teva-MedinCell’s new drug application for drug to treat schizophrenia
Teva Pharmaceuticals and MedinCell’s new drug application (NDA) for their drug, TV-46000/mdc-IRM to treat schizophrenia has been accepted by the US Food and Drug Administration (FDA).Teva Pharmaceuticals and MedinCell’s new drug application (NDA) for their drug, TV-46000/mdc-IRM to treat schizophrenia has been accepted by the US Food and Drug Administration (FDA).
Intended for use as a subcutaneous injection, TV-46000 is an extended-release suspension of risperidone.
This acceptance by regulatory agency is based on results from two Phase III clinical trials – RISE Study and SHINE Study or TV46000-CNS-30078.
RISE, or TV46000-CNS-30072, which is a multi-centre, double-blind, placebo-controlled study, analysed the efficacy of TV-46000 to treat schizophrenia in patients aged between 13 and 65 years.
It saw enrolment of 544 subjects, who were randomised in a 1:1:1 ratio to get either a subcutaneous dose of TV-46000 once monthly (q1M) or once every two months (q2M) or a placebo.
The SHINE Phase III trial evaluated the long-term safety, tolerability and efficacy of subcutaneous dose of TV-46000 given q1M or q2M for up to 56 weeks.