Registration for the trial was open to patients aged 13-65. In the RISE study, patients treated with a monthly subcutaneous risperidone injection (q1M) (n = 183) or once every two months (q2M) (n = 179) experienced a statistically significant delay in time to recurrence compared with placebo (n = 181), the main endpoint of the study, With p <0.0001 per comparison. Subcutaneous injection of q1M and q2M subcutaneous risperidone showed a 80.0% and 62.5% reduction in the risk of recurrence compared with placebo, respectively.
“Schizophrenia is a chronic, progressive and severe mental disorder in which all recurrence can cause cognitive and psychosocial loss, exacerbate long-term outcomes and increase the overall burden on patients, caregivers, families and the health care system. We encourage RISE research results, which demonstrated significant delay in recurrence. Patients in the monthly treatment groups and those who are treated once every two months, “Said Dr. Christer Nordstadt, senior vice president, director of unique clinical development in nature. “We look forward to sharing more detailed results from the RISE study at future scientific conferences, and peer-reviewed scientific publications, as well as exploring options for applying for a new drug approval (NDA potentially using currently available clinical data).”
No new safety signals have been identified that are inconsistent with the known safety profile of other versions of Risperidone. The second study from Teva’s Phase 3 studies (TV46000-CNS-30078 – SHINE study) evaluating the long-term safety and tolerability of subcutaneous risperidone injection across 331 patients, is still ongoing. Its intermediate results are consistent with the safety findings of the RISE study.
“Long-term (LAI) injections for schizophrenia are considered an innovative treatment option that we believe will have a significant impact, yet they tend to be less utilized and offered only at a later stage of disease progression,” Said Christoph Duet, CEO of Madinsell. “The results of the RISE study promise and suggest the potential of risperidone to be a subcutaneous treatment option for patients with schizophrenia.”
Teva will continue to lead the clinical and regulatory development and will be responsible for the commercialization of this potential treatment, with Madensel entitled to milestones for development stages, royalties on net sales and future commercial milestones.
About schizophrenia
Schizophrenia is a chronic, progressive and very limiting mental disorder that affects the way you think, feel and act. Patients experience a variety of symptoms, which may include delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability.
About 1% of the world’s population will develop schizophrenia during their lifetime, and 3.5 million people in the U.S. are currently diagnosed with it. Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to early twenties for men, and late twenties to early. 30s for women.
The long-term course of schizophrenia is characterized by episodes of partial or complete remission that is violated by recurrence that often occurs in the context of a psychiatric emergency and requires hospitalization. About 80% of patients experience multiple recurrences in the first five years of treatment, and any recurrence carries with it a biological risk of loss of function, persistence of treatment and changes in brain morphology.
Patients are often unaware of their disease and its consequences, and contribute to non-compliance with treatment, high rates of discontinuation of treatment, and ultimately, significant direct and indirect health costs as a result of recurrence and subsequent hospitalizations. ,