The USFDA has approved an extended-release injection suspension of risperidone for the treatment of schizophrenia and bipolar I disorder in adults. The application of microsphere technology allows the formulation to deliver long-acting and extended-release risperidone. ##Clinical trial details## The approval was based on the positive findings of three open-label clinical trials involving stable patients with schizophrenia and/or schizoaffective disorder.
Two of the three trials assessed the pharmacokinetics and safety of a single ascending dose of intramuscular extended-release risperidone (n=36), NCT02055287, and the bioavailability of multiple intramuscular injections of extended-release risperidone (n=108), NCT02091388. Another pharmacokinetic study compared a single intramuscular injection of extended-release risperidone at 25mg/50mg vs. a long-acting form of oral risperidone…
