Positive results for the treatment of schizophrenia – global markets

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And the French company Madinsell (Euronext: MEDCL) report positive results for a study designed to evaluate the efficacy of subcutaneous risperidone injection for subcutaneous use as a treatment for patients with schizophrenia. This is a clinical trial in Phase 3.

Registration for the trial was open to patients aged 13-65. Based on the results, patients treated with a monthly or once every two months subcutaneous risperidone injection experienced a statistically significant delay in time to recurrence compared with the control group given placebo. Subcutaneous risperidone injection showed a 80.0% and 62.5% (respectively) reduction in the risk of recurrence compared with placebo.

According to the companies’ reports, 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 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 present study.

Under the plan, Teva will continue to lead the clinical and regulatory development and will be responsible for commercializing the treatment, while the company is entitled to milestones for development stages, royalties on net sales and future commercial milestones.

About 80 million people worldwide will develop schizophrenia
Schizophrenia is a chronic and very limiting mental disorder that affects the way you think, feel and act. Patients experience symptoms such as delusions, hallucinations, disorganized speech or behavior, and impaired cognitive ability.

About 1% of the world’s population (about 78 million people) 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 for onset tends to be in late teens to early teens. The twenties for men, and in the late 1920s to early 1930s 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 all recurrences carry a biological risk of loss of function, persistence of treatment and changes in brain morphology.
And
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.

Dr. Christer Nordstadt, Senior Vice President, Director of Unique Clinical Development in Nature: “Any recurrence of schizophrenia can result in cognitive and psychosocial loss, exacerbate long-term outcomes and increase the overall burden on patients, caregivers, families and the health care system. “Once every two months, 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 (NDA potential using currently available clinical data.”

Christoph Duet, CEO of Madinsell: 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 late stage of disease progression RISE study results promise and suggest the potential of Risperidone to be a subcutaneous treatment option schizophrenia.”