A phase 3 clinical trial of extended-release subcutaneous risperidone injection (TV-46000/mdc-IRM) developed by Teva Pharmaceuticals and MedinCell recently reported positive results in treating patients with schizophrenia. Data from the study showed that patients who received the treatment had a statistically significant delay in time to relapse as compared to placebo.
The phase III TV46000-CNS-30072 the Risperidone Subcutaneous Extended-Release Study (RISE study) analysed the efficacy of risperidone extended-release injectable suspension for subcutaneous use for treating schizophrenia patients aged 13 to 65. The time to impending relapse was the trial’s primary endpoint.
TV-46000/mdc-IRM is a once-monthly or once-every-two-months atypical antipsychotic risperidone formulation. The trial enrolled 544 patients who were randomised into 1:1:1 ratio and were given either subcutaneous injection of risperidone monthly (q1M) or once every two months (q2M), or placebo. The subcutaneous risperidone injection q1M and q2M showed 80% and 62.5% reduction in the risk to relapse versus placebo, respectively.
Teva Specialty Clinical Development head, senior vice-president Christer Nordstedt said: “Schizophrenia is a chronic, progressive and severe mental disorder in which every relapse has the potential to cause cognitive and psychosocial loss, worsen long-term outcomes, and increase the overall burden for patients, caregivers, families, and the healthcare system.
The Phase II TV46000-CNS-30078 – SHINE study analysing the long-term safety and tolerability of the investigational subcutaneous risperidone injection in 331 patients is also progressing.