New data provide schizophrenia treatment insights into switching to UZEDY® extended-release injectable suspension from invega sustenna®

Published on

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), have announced the presentation of seven studies from its long-acting injectable (LAI) schizophrenia research program. Presentations include data informing clinical strategies for switching patients to UZEDY, an extended-release injectable suspension of risperidone for subcutaneous use every one or two months for the treatment of schizophrenia in adults, from a once-monthly intramuscular injection of Invega Sustenna. The results were presented at the Psych Congress Elevate 2024 Annual Meeting taking place from May 30 – June 2 in Las Vegas, Nevada.

“UZEDY is a long-acting formulation of risperidone with an innovative delivery system that requires no loading dose or oral supplementation and can be dosed at one- or two-month intervals to help with prevention of relapse. It is administered subcutaneously under the skin instead of intramuscularly, which is an important feature to discuss with patients,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. “We are proud to share these clinical insights that may help healthcare providers understand more about switching between long-acting options for their schizophrenia patients.”

In a population pharmacokinetic (PopPK) analysis, simulations were performed to predict PK exposures when switching to UZEDY 4 - 6 weeks at steady state after the last injection of once-monthly paliperidone palmitate. Model simulations showed that switching to UZEDY at four weeks after the last dose of once-monthly paliperidone palmitate yielded generally higher PK parameters, both within the total active moiety range for oral risperidone. Comparable doses included UZEDY at 125 mg (once-monthly dosing) or 250 mg (once-every-two-months dosing) to 234 mg of once-monthly paliperidone palmitate. The analysis aims to address the knowledge gap as limited clinical data currently exist to inform strategies for switching between the various available LAI treatment options with differing PK properties.1

Any switching strategy should be determined by clinicians on an individual basis, considering factors such as patient preference, scheduling convenience and potential tolerability issues or risk of symptom breakthrough.

“The treatment and management of schizophrenia is a journey and many patients may see their needs evolve over time due to challenges with symptom control or simply due to a change in dosing preference,” said Christoph Correll, MD, Professor of Psychiatry at the Zucker School of Medicine, Hempstead, NY. “Researchers and clinicians like myself rely on analyses like these to understand strategies for switching between long-acting injectable options and help ensure each of our patients is on the most appropriate treatment.”

Additional key data being presented at Psych Congress Elevate 2024:

New data from the RISE (Risperidone Subcutaneous Extended-Release Study) and SHINE (A Study to Test TV-46000 for Maintenance Treatment of Schizophrenia) Phase 3 pivotal studies that supported the FDA approval of UZEDY for adults. The updated analysis evaluated the safety of once or twice monthly UZEDY for young adults (aged 18-21) who participated in the RISE and SHINE studies. No unexpected safety concerns or clinically meaningful trends in adverse events were observed.1

Qualitative data from four ADVANCE (Attitudes Driving Regional Differences in LAI Antipsychotic Utilization for Schizophrenia Among Healthcare Professionals, Patients and Caregivers) surveys showing:

  • Ten psychiatrists, who average 18 years of experience and spend 45% of their practice time in hospital-based outpatient clinics, were interviewed and expressed that treatment priorities for patients with schizophrenia may differ depending on the care setting, but all described the potential benefits of LAIs for both patients and clinicians. 1
  • Seven psychiatric nurses, who average 17 years of experience and spend 47% of their practice time in outpatient clinics, were interviewed and expressed positive views of LAIs but had a limited understanding of specific LAI molecules and prioritized the benefits of LAIs for nonadherent patients, highlighting potential unmet HCP educational needs. 1
  • In the patient and caregiver surveys, 20 patients and 19 caregivers completed a 60-minute interview regarding the use of LAIs in schizophrenia. Most patient-reported perceptions regarding advantages of LAIs were convenience (n=7) and fewer side effects compared with oral antipsychotics (n=3). Caregivers emphasized the importance of a patient’s quality of life along with symptom management and expressed advantages of LAIs, including convenience to both the person with schizophrenia and the caregiver (n=10 and n=7, respectively). 1

Below is the full set of UZEDY and long-acting injectable data presented by Teva at Psych Congress Elevate 2024.

Find further information and read the original press release.

For more news from the world of long-acting therapeutics, sign up to the CELT's LONGEVITY mailing list here for regular updates.