Okedi (Risperidone ISM®) is a monthly, extended-release injectable antipsychotic intended for the treatment of schizophrenia in adults in whom oral risperidone has been shown to be tolerable and effective. This drug has been developed and patented by the pharmaceutical company Rovi, which has announced that the European Commission has authorized its marketing.
From the first injection, the patient is provided with immediate and sustained plasma levels of the drug, without the need for loading doses or supplementation with oral risperidone. ISM is a technological platform for drug delivery based on the in situ creation of biodegradable matrices after the administration of a liquid carrier.
As reported by the company, this allows therapeutic levels of the drug to be obtained quickly after administration, without the need to use oral or booster doses or additional loading injections to reach and maintain these levels in a predictable and sustained manner over time.
From the first injection, the patient is provided with immediate and sustained plasma levels of the drug, without the need for loading doses or supplementation with oral risperidone.
“We are very excited about the approval of Risperidone ISM® by the European Commission because we believe that our drug will be able to contribute to the clinical management of schizophrenic patients. Likewise, we hope to be able to launch the product in Europe in the second quarter of 2022”, said Juan López-Belmonte Encina, president and CEO of Rovi.
Safety and efficacy of Okedi in patients with schizophrenia
The pivotal study Prisma-3 in which the safety and efficacy of Okedi was verified in patients with schizophrenia has served as the basis for the European Commission to approve this medicine. The results of the trial show that with two different doses – 75 mg and 100 mg, monthly – the pre-specified objectives in the key primary and secondary efficacy variables for the treatment of patients with acute exacerbation of schizophrenia have been achieved.
Statistically significant improvement for both efficacy outcomes occurred eight days after the first injection. The most frequently reported side effects were increased blood prolactin (7.8%), headache (7.3%), hyperprolactinemia (5%), and weight gain (4.8%).
Patients who successfully completed the double-blind phase of the study were offered to continue in a long-term extension phase (12 months), in which treatment with Risperidone ISM® (75 mg or 100 mg) was administered every four months. weeks open. New, clinically stable patients were also included in this phase. Long-term treatment was found to be effective, safe and well-tolerated in adult patients with schizophrenia, regardless of the initial severity of their illness or whether they had previously been treated with Risperidone ISM® during an acute exacerbation or switched from stable doses. of oral risperidone.
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