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 or 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 study’s primary goal was the time to relapse.
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.
It saw enrolment of 331 subjects, with the frequency of all adverse events (AEs), including that of serious AEs being the primary goal.
This trial is currently underway and interim results were reported to be in line with data from the RISE Study.
MedinCell CEO Christophe Douat said: “NDA file acceptance marks a major milestone for MedinCell, for our extended-release injectable technology, and for patients living with schizophrenia.
“Through our strategic collaboration with Teva, we move one step closer towards helping patients and care-providers gain access to our extended-release subcutaneously injectable risperidone.”
Teva will be responsible for the clinical development and regulatory activities and will oversee the marketing of the therapy candidate.
MedinCell is eligible to get development and commercial milestone payments in the future besides royalty payments on net product sales.