The US Food and Drug Administration (FDA) has accepted Teva Pharmaceuticals and MedinCell’s new drug application (NDA) for their drug, TV-46000/mdc-IRM, to treat schizophrenia.
TV-46000 is an extended-release suspension of risperidone intended for use as a subcutaneous injection.
The FDA accepted the application based on results from two Phase III clinical trials, namely RISE Study or TV46000-CNS-30072 and SHINE Study or TV46000-CNS-30078.
The multi-centre, double-blind, placebo-controlled RISE Study analysed the efficacy of TV-46000 to treat schizophrenia in patients aged 13 to 65 years.
It enrolled 544 subjects, who were randomised in a 1:1:1 ratio to receive either a subcutaneous dose of TV-46000 once monthly (q1M) or once every two months (q2M) or a placebo.
The time to relapse was the trial’s primary goal.
In January, Teva and MedinCell reported positive results from the Phase III RISE study.
The Phase III SHINE Study assessed the long-term safety, tolerability and efficacy of subcutaneous dose of TV-46000 given q1M or q2M for up to 56 weeks.
It enrolled 331 subjects, with the frequency of all adverse events (AEs), including serious AEs forming 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 continue to handle the clinical development and regulatory activities and will oversee the marketing of the therapy candidate.
Meanwhile, MedinCell is eligible to receive development and commercial milestone payments in the future, as well as royalty payments on net product sales.
A chronic and severely debilitating mental condition, schizophrenia can impact a person’s thinking, feelings and behaviour.
Symptoms of the disorder include delusions, hallucinations, disorganised speech or behaviour and impaired cognitive skills.