Uzedy Approved for Maintenance Treatment of Bipolar I Disorder

The Food and Drug Administration (FDA) has approved Uzedy^® (risperidone extended-release injectable suspension) as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.

Uzedy utilizes proprietary technology to control the steady release of risperidone, an atypical antipsychotic. Following the first subcutaneous injection, therapeutic blood concentrations are reached within 6 to 24 hours. The product was previously only indicated for the treatment of schizophrenia in adults.

The approval for bipolar I disorder was based on existing Uzedy clinical trial data, as well as findings from previous studies evaluating another long-acting risperidone injectable. Results showed time to relapse was delayed in patients receiving a different risperidone long-acting injection, administered once every 2 weeks, either as monotherapy or as adjunctive therapy, compared with those receiving placebo. 

The most common adverse reactions with risperidone in patients with bipolar disorder include increased weight, tremor and parkinsonism. 

Following establishment of tolerability with oral risperidone, Uzedy may be started as a once monthly injection for monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder. Uzedy is administered subcutaneously into the abdomen or upper arm by a health care professional.

Patients receiving risperidone long acting intramuscular (IM) injections once every 2 weeks may switch to Uzedy starting at least 5 weeks after the last risperidone IM dose. Uzedy administered once every 2 months is not recommended for the maintenance treatment of bipolar I disorder. 

This article originally appeared on MPR