Medincell’s UZEDY, a subcutaneous risperidone injection available in one- and two-month versions, became the company’s first product to be sold using its long-acting injection technology. It was approved by the U.S. Food and Drug Administration in 2023 for treating schizophrenia in adults. UZEDY provides a new way for patients to manage their medication consistently. The development and marketing of UZEDY are handled by Medincell’s partner, Teva Pharmaceuticals. Medincell gets royalties from sales and also receives payments based on achieving certain milestones during development and commercialization.
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The long-acting injectable olanzapine, called TV-44749 or TEV-749, is being tested in several Phase 3 studies as part of the SOLARIS trial. These studies are looking at the long-term safety, effectiveness, and metabolic effects, including weight gain, in adults with schizophrenia. Other research is exploring the real-world impact of not taking oral olanzapine regularly, showing how missed doses can cause relapse and increase healthcare use. The SONAR study collects input from healthcare professionals about dealing with side effects of olanzapine and the challenges they face when prescribing long-acting forms.
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For UZEDY, which has the code TV-46000, recent studies look at how patients do when they start this subcutaneous long-acting antipsychotic compared to an intramuscular version of paliperidone palmitate in hospitalized schizophrenia patients. Researchers have also done modeling to understand how patients switch from monthly aripiprazole injections to TV-46000. Healthcare professionals have shared their experiences with TV-46000 through qualitative research, giving a better understanding of how it’s used in real life.
The RISE study uses machine learning to find out what factors can predict when patients treated with TV-46000 or a placebo might relapse. These insights help in identifying risks and tailoring treatment plans to improve patient outcomes. This approach reflects a growing interest in using advanced technologies to support mental health treatments.
Overall, these efforts show Medincell’s dedication to improving long-acting injectable treatments, providing new options for people with schizophrenia and tackling needs that have not been fully met by current treatments. The company continues to focus on addressing the challenges patients and clinicians face to enhance quality of care.
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