MADRID, 2 Abr. (EUROPA PRESS) –
Rovi has received approval from the United States Food and Drug Administration (FDA) for its drug Risvan as a treatment for schizophrenia in adults, as reported this Tuesday by the pharmaceutical company to the National Market Commission. Securities (CNMV).
Specifically, the company announced this Tuesday that the FDA has authorized the marketing in the United States of Risvan (risperidone ISM) for the treatment of schizophrenia in adults.
Rovi has explained that the drug risperidone ISM is a prolonged-release injectable antipsychotic developed and patented by the pharmaceutical company for the treatment of schizophrenia in adults, which, from the first injection, provides plasma levels of the drug in an “immediate and sustained” manner. without requiring loading doses or supplementation with oral risperidone.
Thus, this approval is based on the positive results of the pivotal ‘prisma-3’ study on the efficacy and safety of risperidone ISM in patients with schizophrenia.
The firm has detailed that the results obtained in this study demonstrate that with two different doses (75 milligrams (mg) and 100 mg monthly) the pre-specified objectives in the key primary and secondary efficacy variables for the treatment of patients with moderate to severe symptoms of schizophrenia.
“We are very excited about the approval of risvan by the FDA because we believe that our medicine will be able to contribute to the clinical management of schizophrenic patients, helping to improve adherence to treatment,” stressed the president and CEO of Rovi, Juan López. -Belmonte Encina.
