Teva Pharmaceuticals Industries Ltd. (NYSE:TEVA) and MedinCell have released positive results from the TV46000-CNS-30072 study. The Risperidone Subcutaneous Extended-Release Study (RISE) is a third phase clinical study designed to assess TV-46000/mdc-IRM as a schizophrenia treatment.
Risperidone injection delays relapse in schizophrenia patients
Enrolment for the study was open to schizophrenic patients aged 13 years to 65 years. Patients in the study received the experimental subcutaneous risperidone injection monthly (q1M) or once after two months (q2M). The subjects experienced considerable delay in relapse time compared to the placebo group. There was an 80% and 62.5% reduction in relapse risk in the subcutaneous risperidone injection q1M and q2M respectively compared to the placebo group.
Christer Nordstedt, Teva’s SVP Head of Speciality Clinical Development said that schizophrenia is a progressive, severe, and chronic mental disorder whereby relapses can potentially cause psychosocial and cognitive loss. Equally, the relapses can worsen long-term results and increase the burden for families, caregivers, patients, and the healthcare system. Nordstedt said that they are encouraged by the positive RISE study results which showed a significant delay in relapse time for patients in both treatment groups. The company will be sharing detailed results from the study in peer-reviewed publications and scientific conferences. Nordstedt also said that they will explore options to file a potential NDA using the available data.
Teva conducting phase 3 TV46000-CNS-30078 study
Interestingly the company has not identified new safety signals inconsistent with the current safety profile of risperidone formulations. Teva’s second phase 3 studies (TV46000-CNS-30078- the SHINE study) assessing the tolerability and safety of the experimental subcutaneous risperidone injection in 331 patients is currently underway. So far preliminary results are in line with the RISE study safety findings.
MedinCell CEO, Christopher Douat said that long-acting injectable for schizophrenia is an innovative treatment alternative. He said that they expect the LAI to offer a significant difference even though they become an option at the late stages of the diseases. Douat added that the RISE study results have been encouraging and demonstrate risperidone’s potential as a subcutaneously administered schizophrenia treatment alternative.