Uzedy, Long-Acting Schizophrenia Treatment, Gets FDA Approval

The Food and Drug Administration (FDA) has approved Uzedy^™ (risperidone extended-release injectable suspension) for the treatment of schizophrenia in adults.

Uzedy is a subcutaneous (SC), long-acting formulation of risperidone, an atypical antipsychotic, that utilizes proprietary technology to control the steady release of the drug. Following the first SC injection, therapeutic blood concentrations are reached within 6 to 24 hours.

The approval of Uzedy was based on the established effectiveness of oral risperidone as well as the RISE trial (ClinicalTrials.gov Identifier: NCT03503318), a withdrawal study that included 544 patients who met the DSM-5 criteria for schizophrenia. The trial consisted of a 12-week open-label oral risperidone (2-5mg) stabilization phase, followed by a placebo-controlled phase in which patients were randomly assigned 1:1:1 to receive Uzedy (once monthly or every 2 months) or placebo.

The primary endpoint was the time to impending relapse. Results showed treatment with Uzedy (once monthly or every 2 months) was associated with a statistically significant delay in the time to relapse compared with placebo (P <.0001). The risk of relapse was reduced by 80.0% and 62.5% in the once monthly and every 2-month groups, respectively, vs placebo. The safety profile of Uzedy was found to be consistent with that of other risperidone formulations.

Findings from the SHINE study (ClinicalTrials.gov Identifier: NCT03893825), which evaluated the safety of maintenance treatment (up to 56 weeks) with Uzedy, aligned with those observed in the RISE study.

Uzedy is expected to be available in the coming weeks. It is supplied in a kit containing a single-dose prefilled syringe and needle; the dosage strengths include: 50mg/0.14mL, 75mg/0.21mL, 100mg/0.28mL, 125mg/0.35mL, 150mg/0.42mL, 200mg/0.56mL, and 250mg/0.7mL.

Uzedy must be administered by a health care professional as an abdominal or upper arm SC injection. For patients who have never taken risperidone, tolerability with oral risperidone should be established prior to initiating Uzedy.