Teva Pharmaceuticals and MedinCell have reported positive results from the Phase III TV46000-CNS-30072 the Risperidone Subcutaneous Extended-Release Study (RISE study) of investigational TV-46000/mdc-IRM for treating patients with schizophrenia.
TV-46000/mdc-IRM or extended-release subcutaneous risperidone injection is a once-monthly or once-every-two-months atypical antipsychotic risperidone formulation.
A chronic, progressive and severely debilitating mental disorder, Schizophrenia affects how a person thinks, feels and acts.
The multi-centre, randomised, double-blind, placebo-controlled RISE study analysed the efficacy of risperidone extended-release injectable suspension for subcutaneous use for treating schizophrenia patients aged 13 to 65.
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.
Time to impending relapse was the trial’s primary endpoint.
Data from the study showed that patients who received the treatment had a statistically significant delay in time to relapse as compared to placebo, thus meeting the primary endpoint.
In addition, 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.
“We are encouraged by the results of the RISE study, which demonstrated a marked delay in time to relapse for patients in both the monthly and once-every-two months treatment groups.”
The safety profile of the risperidone formulations was observed to be in line with the known ones.
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.
Last February, Teva Pharmaceutical reported positive data from two Phase II/III clinical trials of Ajovy (fremanezumab) conducted to treat migraine patients in Japan.