Rovi launches its schizophrenia treatment in Spain

Juan Lopez-Belmonte, President of Rovi.

Rovi launched the marketing in Spain of Okay (Risperidone ISM) for treatment of schizophrenia in adults thus we are proceeding with the plan to market this new drug, which is already present on the markets in Germany, the United Kingdom and Austria.

This drug is a new injectable sustained-release antipsychotic administered every four weeks for the treatment of schizophrenia in adults, in which the tolerability and effectiveness of oral risperidone have been established, based on the ISM technology developed and patented by Rovi. From the first injection, achieves therapeutic drug concentrations similar to those achieved with oral risperidone keeping them constant during the administration period (28 days), without the need for a loading dose or supplementation with oral risperidone.

Improved treatment adherence

“Okedi has a distinct pharmacological profile thanks to our ISM technology, which enables the immediate and sustained release of an antipsychotic without the need for a loading dose or supplementation with oral risperidone. These characteristics, together with the efficacy and safety results obtained in the Prisma-3 clinical trial, may contribute to increasing treatment adherence and improving the therapeutic alliance between the healthcare professional and the patient from day one who has suffered a relapse of schizophrenia, with the aim of being able to facilitate their functional recovery and reintegration into society,” commented Javier Martínez, Rovi’s Medical Director.

Eduard Vieta Pascual, professor of psychiatry and head of the psychiatry and psychology service at the Hospital Clinic de Barcelona, ​​explained that “there are many types of innovation”. “In this case, we welcome a new formulation of a classic drug, risperidone, which provides immediate and sustained plasma levels of the drug, without requiring a loading dose or supplementation with oral risperidone. With this, we are introducing a new treatment alternative for people with schizophrenia,” he says.

Mikel Bernardo Arroyo, coordinating professor of psychiatry at the Faculty of Medicine of the University of Barcelona and senior consultant at the Hospital Clinic of Barcelona, ​​emphasizes that “the arrival of this new presentation of a leading antipsychotic is good news, as the inclusion of monthly risperidone with long-term release provides an option that is not only effective and with proven tolerability, but also contributes to the sustainability of care needed by patients with schizophrenia, care that can be extended over time. These factors are related to the attitude of the patient to the drug, that of the caregivers, and also that of the health administration. These are factors that define a framework more conducive to the development of a therapeutic alliance between all parties involved in the process of recovery from an illness such as schizophrenia, which continues to be a challenge for psychiatry and public health.

About the Prisma-3 core survey

The positive results of pivotal Prisma-3 study on the efficacy and safety of Okedi in patients with schizophrenia showed that two different doses (75 mg and 100 mg, monthly) achieved prespecified goals in key primary and secondary efficacy variables for the treatment of patients with acute exacerbation of schizophrenia. The primary efficacy endpoint, Panss total score (mean difference, 95 percent CI), was significantly improved from baseline to day 85 with Risperidone ISM 75 and 100 mg, with placebo-adjusted differences of -13.0 (-17, 3 to -8.8; p

There were also significantly improved mean changes for the key secondary endpoint, Okedi CGI-S score, from baseline to day 85 compared with placebo, of -0.7 (-1.0 to -0.5; p<0 .0001) for both doses. The statistically significant improvement in efficacy in the PANSS it was still observed 8 days after the first injection for the 100 mg dose, and in the case of the CGI-S a significant improvement was observed at day 8 for both doses.

The most frequently reported adverse drug reactions were increased blood prolactin (11.7%), hyperprolactinemia (7.2%), akathisia (5.5%), headache (4.8%), somnolence (4.1%) , weight gain (3.8%), injection site pain (3.1%) and dizziness (3.1%). No new or unexpected security-related information is recorded. Similarly, patients who successfully completed the double-blind phase were asked to continue in a long-term extension phase (12 months) where treatment with Okedi (75 mg or 100 mg) was administered every four weeks in an open-label fashion. New, clinically stable patients (“de novo” patients) are also included in this open-label phase of the study.

It was noted that long-term treatment has been effective, safe and well tolerated by adult patients with schizophreniaregardless of the initial severity of their disease or whether they were previously treated with Okedi during an acute exacerbation or transitioned from stable doses of oral risperidone. Its overall relapse rate of 10.7 percent demonstrated at 12 months, as well as the re-hospitalization rate, where only 9 of 215 patients required hospitalization, demonstrate the prolonged effect of Okedi in controlling the psychotic symptoms of schizophrenia. In terms of long-term tolerability results, Okedi showed an adverse event withdrawal rate of 3.2 percent (7 of 215 patients) for those adverse events of most concern to patients, such as akathisia, decreased libido, extrapyramidal disorders, or weight profit.

Although it may contain statements, data or notes from health institutions or professionals, the information contained in Medical Writing is edited and prepared by journalists. We recommend that the reader consult a health professional for all health-related questions.

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