On January 7, Teva Pharmaceuticals and MedinCell announced positive results from their Phase III trial (RISE Study) evaluating mdc-IRM (risperidone) as a maintenance treatment in adults and adolescents with schizophrenia. Schizophrenia is a chronic progressive disorder; each relapse increases the burden of disease for patients and carers and has the potential to worsen long-term outcomes. In the RISE Study, participants treated with mdc-IRM saw a statistically significant increase in time to relapse compared to placebo. Additionally, the safety profile was consistent with the known safety profile of other risperidone formulations. Teva Pharmaceuticals and MedinCell are now looking to the option of a new drug application (NDA) based on the available clinical data.
Non-compliance is an important factor that can increase the risk of relapse in schizophrenia patients, and is one of the key challenges of treating schizophrenia. In order to try to increase compliance, an increasingly used strategy in the schizophrenia market is long-acting injectable (LAI) drugs, which have a favorable dosing strategy compared to oral therapies. mdc-IRM is an extended-release injectable suspension for subcutaneous use, which can be administered once monthly or once every two months. In the RISE Study, patients treated with mdc-IRM administered once monthly and once every two months demonstrated a reduction of 80% and 62.5% in the risk to relapse compared to placebo, respectively.
Risperidone is one of the most widely-used antipsychotics for schizophrenia treatment, so if approved mdc-IRM is likely to see good uptake as physicians are highly familiar with risperidone, and it has a competitive edge of being the first risperidone formulation with a once every two months dosing regimen. However, it will have to directly compete with Indivior’s Perseris (risperidone), an LAI with once-monthly dosing that launched in 2019 in the US and will have first-to-market advantage. GlobalData forecasts Perseris’ global sales to reach $173M in 2026.
As well as the other risperidone formulations, mdc-IRM will also face an increasingly competitive schizophrenia market with LAIs being developed for many of the other antipsychotic drugs used in schizophrenia treatment. Of note, Janssen’s PP6M (paliperidone palmitate 6-monthly) is awaiting a decision from the European Medicines Agency (EMA), and if approved would be the first LAI schizophrenia treatment with a twice-yearly dosing regimen, giving it a big advantage over the LAIs with shorter dosing regimens, including MDC-IRM. GlobalData forecasts PP6M’s global sales to reach $5.3B in 2026.