FDA Approves Risperidone Extended-Release Injectable Suspension for Schizophrenia

The FDA has approved risperidone (Uzedy, Teva and MedinCell), an extended-release injectable suspension and long-acting subcutaneous atypical antipsychotic injection for the treatment of schizophrenia in adults.

According to a press release, the injection utilizes technology to control the steady release of risperidone and therapeutic blood concentrations are reached within 6 to 24 hours of a single dose. It also offers flexible 1- and 2-month dosing intervals.

Schizophrenia is a chronic, progressive, and severe debilitating mental health disorder that has significant impacts on how patients think, feel, and act. An estimated 80% of patients with schizophrenia experience multiple relapses over the first 5 years of treatment, often due to suboptimal treatment adherence with oral antipsychotic medications. Each relapse has a biological risk of loss of function, treatment refractoriness, and changes in brain morphology, making ongoing treatment particularly challenging.

“Treatments for schizophrenia are largely prescribed as daily oral medications, which can present challenges with adherence due to missed doses,” said Christoph Correll, MD, a professor of psychiatry at the Zucker School of Medicine, in a press release. “Lack of adherence to treatment with oral antipsychotics is the most common cause of relapse in schizophrenia, so there’s a role for therapies that are dosed in 1- or 2-month dosing intervals to help prevent relapse.”

The approval is based on data from the phase 3 RISE and SHINE trials, which evaluated risperidone in patients with schizophrenia. The RISE study was a multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy of risperidone extended-release injectable suspension for subcutaneous use in patients aged 13 to 65 years with schizophrenia. The trial randomized 544 patients to receive a subcutaneous injection once monthly, once every 2 months, or placebo, with the primary endpoint of time to impending relapse.

Similarly, the SHINE study was designed to evaluate the use of risperidone subcutaneously administered once every month or every 2 months for up to 56 weeks in 336 patients aged 13 to 65 years with schizophrenia. The primary endpoint was the frequency of all adverse events (AEs), including serious AEs.

According to the press release, treatment with risperidone extended-release injectable suspension reduced the risk of relapse by up to 80% in clinical studies.

“As a clinician, I am excited to now have a new treatment option that reduces the risk of relapse for this complex disease and helps address some of the barriers around receiving schizophrenia treatment,” Correll said in the press release.

In a companion survey of study participants from the RISE and SHINE trials, 89% of patients and 92% of health care providers rated administration of risperidone extended-release subcutaneous injectable suspension as easy. Additionally, 70% of patients agreed that the treatment provided a better injection experience than their previous long-acting injectables and 30% agreed that they had a better injection experience with their prior long-acting injectable medication. Given the choice between continuing to take the clinical trial medication or returning to their previous treatment, 90% of patients chose to continue using risperidone.

The list price for Uzedy ranges from $1232 to $3080 per month, depending on dosage strength, although actual costs for individual patients are anticipated to be lower. Patients may also be eligible for participation in the co-pay assistance program.

REFERENCE

Teva and MedinCell Announce FDA Approval of Uzedy (risperidone) Extended-Release Injectable Suspension, a Long-Acting Subcutaneous Atypical Antipsychotic Injection, for the Treatment of Schizophrenia in Adults. News release. Teva. April 28, 2023. Accessed May 1, 2023. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2023/Teva-and-MedinCell-Announce-FDA-Approval-of-UZEDY-risperidone-Extended-Release-Injectable-Suspension-a-Long-Acting-Subcutaneous-Atypical-Antipsychotic-Injection-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx