Teva Pharmaceutical Industries Limited (TEVA) and MedinCell report promising findings from (TV46000-CNS-30072) (the RISE- Risperidone Subcutaneous Extended-release) research, a phase 3 clinical trial aimed to assess the effectiveness of TV-46000/MDC-MRI (subcutaneous injectable long-release risperidone suspension) as a treatment for schizophrenia patients.
Patients between the ages of 13 and 65 are open to inclusion in this clinical trial. The study satisfied its primary criteria of efficacy: delaying the regression period of patients. In the RISE trial, patients treated with an experimental subcutaneous risperidone injection reached the primary endpoint, which was a clinically relevant relapse interval compared with placebo-treated patients. On the other hand, the subcutaneous risperidone injections tested showed an 80% and 62.5% decrease in the risk of relapse, respectively, compared with placebo.
According to Christer Nordstedt, MD, Ph.D., Senior Vice President and Director of Advanced Clinical Research of TEVA, the management is anticipating discussing the comprehensive findings of the RISE analysis at upcoming scientific conferences and peer-reviewed journals, as well as reviewing avenues for potential submission of an application for approval. No new product safety threats associated with the known safety profile of other formulations of risperidone have been reported.
A second Phase 3 Teva trial (SHINE study, TV46000-CNS-30078) is ongoing to determine the efficacy and long-term tolerance of experimental subcutaneous risperidone injection in 331 patients. The interim findings are consistent with the product safety outcomes of the RISE report.
Teva will continue to lead and be responsible for the commercialization of the drug research and regulatory framework for this treatment. MedinCell may benefit from payments relating to the passage of such production phases, net revenue royalties, and payments relating to potential commercial milestones.
Teva Pharmaceutical Industries Limited (TEVA) was stable at -0.18% on Thursday to close the trading at $11.07. Over the week stock has added about 15% to its value raising the market capitalization of the company to $12.16 billion.