Admin_Adham
The FDA has approved an expanded indication for risperidone (Uzedy, Teva) extended-release injectable suspension, allowing it to be used for the maintenance treatment of bipolar I disorder in adults, either as monotherapy or in combination with lithium or valproate.
Uzedy was first approved in the US in 2023 for the treatment of adults with schizophrenia.
For bipolar I disorder, Uzedy was approved in three once-monthly dosing options (50 mg, 75 mg, and 100 mg).
The approval of Uzedy for the maintenance treatment of bipolar I disorder was based on previous findings of safety and efficacy of past risperidone formulations approved for the treatment of bipolar I disorder, the company said in a statement.
Approval was also tied to the efficacy, long-term safety and tolerability of Uzedy for the treatment of schizophrenia, including the RISE trial and SHINE study, both phase 3 pivotal studies, the company added.
“Bipolar I disorder carries profound implications for a person’s life and is linked to suboptimal long-term outcomes, with treatment adherence to daily oral options frequently presenting as a major impediment to effective care,” Craig Chepke, MD, medical director, Excel Psychiatric Associates, Huntersville, North Carolina, said in the statement.
“The FDA’s decision to expand the indication for Uzedy may help those living with [bipolar I disorder]. As a clinician, I am excited to now have a new treatment option for this complex disease,” Chepke said.
Uzedy can cause serious side effects, especially in the elderly, and is not approved for use in patients with dementia-related psychosis. Complete prescribing information is available online.
