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.
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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.