Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., unveiled findings from seven studies within its long-acting injectable (LAI)
schizophrenia research program at the Psych Congress Elevate 2024 Annual Meeting in Las Vegas. The presentations focused on
UZEDY, an extended-release injectable risperidone for subcutaneous use, designed for monthly or bi-monthly administration to treat schizophrenia in adults. The clinical data presented included strategies for transitioning patients to UZEDY from once-monthly intramuscular injections of
Invega Sustenna.
Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva, highlighted UZEDY’s innovative delivery system, which requires no loading dose or oral supplementation, making it an essential option for preventing relapse in schizophrenia patients. Administered subcutaneously, UZEDY offers dosing flexibility and potentially improved patient compliance.
A population pharmacokinetic (PopPK) analysis simulated the pharmacokinetic (PK) exposures when switching to UZEDY four to six weeks after the last dose of once-monthly paliperidone palmitate. These simulations revealed that switching to UZEDY at four weeks resulted in higher PK parameters within the active moiety range for oral risperidone. Doses of UZEDY at 125 mg (monthly) or 250 mg (bi-monthly) were comparable to 234 mg of paliperidone palmitate. This analysis aims to address the knowledge gap in switching strategies between LAI treatments with different PK properties.
Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, emphasized the importance of understanding these switching strategies as patients’ treatment needs evolve over time. The data presented at the Psych Congress included results from the Phase 3 RISE and SHINE studies, which supported the FDA approval of UZEDY. These studies evaluated the safety of UZEDY in young adults aged 18-21 and found no new or unexpected safety concerns.
The ADVANCE survey provided insights into real-world experiences with LAI schizophrenia treatments. Psychiatrists and psychiatric nurses highlighted the potential benefits of LAIs, such as improved patient compliance and treatment adherence. However, they also identified gaps in understanding specific LAI molecules and the need for further education among healthcare providers.
Patients and caregivers shared their perspectives on LAI treatments, citing convenience and fewer side effects compared to oral antipsychotics as significant advantages. Caregivers particularly valued the impact of LAIs on the quality of life and symptom management for patients.
Overall, the studies presented by Teva underscore the clinical utility of UZEDY in managing schizophrenia and its role in preventing relapse, thus providing valuable insights for healthcare providers in optimizing treatment strategies for their patients.
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