14 original presentations describing improvements in patient-centered outcomes, symptoms over time, as well as patient and healthcare professional preferences and treatment experiences with mdc-IRM will be communicated by MedinCell’s partner Teva Pharmaceuticals.
mdc-IRM [Teva’s codename: TV46000], a subcutaneous risperidone injectable suspension for the treatment of patients with schizophrenia, is the most advanced investigational product based on MedinCell’s BEPO® technology.
Ongoing New Drug Application review by FDA could lead to mdc-IRM commercialization as early as 2022 by Teva in the U.S., provided marketing authorization. MedinCell is eligible for development milestones, royalties on net sales and future commercial milestones.
“The presentation by Teva of the Pivotal Phase 3 data will provide comprehensive insights into the potential of mdc-IRM for the treatment of schizophrenia, said Christophe Douat, CEO of MedinCell. The findings should confirm the power of our long-acting injectable technology that enables us to develop a growing portfolio of breakthrough innovative treatments.”
TV46000 – Data presentation by Teva at Psych Congress 2021
- Efficacy and Safety of Subcutaneous Risperidone Injectable (TV-46000) in Patients With Schizophrenia: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study (RISE Study)
- TV-46000, a Long-Acting Subcutaneous Risperidone Injectable, Demonstrated Improved Patient-Centered Outcomes in Patients With Schizophrenia
- TV-46000 Provided Continued Symptom Improvement in Patients With Schizophrenia During the Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention RISE Study
- Robustness of TV-46000 Efficacy Data from RISE: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study in Patients With Schizophrenia
- Behavioral-, Metabolic-, Endocrine-, and Cardiovascular-Related Adverse Events in Patients With Schizophrenia Treated With TV‐46000
- Efficacy and Safety of TV-46000, Subcutaneous Long-Acting Injectable Risperidone, by Injection Site (Upper Arm, Abdomen): Post Hoc Analysis of the Phase 3 RISE Study
- Contingency Planning and Risk Mitigation Strategies for a Schizophrenia Relapse Prevention Trial During the COVID-19 Pandemic
- Annual Schizophrenia-Related Medical Resource Utilization and Costs Among Patients in the United States Utilizing Atypical Antipsychotic Agents: An Analysis of a Commercial Claims Database
- Treatment Patterns Among Patients in the United States Utilizing Long-Acting Injectable Antipsychotic Agents: An Analysis of a Commercial Claims Database
- Retrospective Analysis of a Commercial Claims Database for Predictors for Initiation of Atypical Long-Acting Injectable Antipsychotic Agents
- Patient Preferences and Treatment Experiences With TV-46000, a Long-Acting Subcutaneous Injectable Risperidone Formulation
- Health Care Professional Preferences and Treatment Experiences With TV-46000, a Long-Acting Injectable Risperidone Formulation
- Determination of Flexible Dose Regimens for TV-46000, a Risperidone Extended Release Suspension for Subcutaneous Injection in Development for the Treatment of Schizophrenia
- Exposure-Response Analysis to Assess the Relationships Between TV 46000 Pharmacokinetic Exposure Parameters, Prevention of Impending Relapse and Adverse Events
- Network Meta-Analysis of Cohort Studies Involving Oral and Long-Acting Injectable Antipsychotic Agents: Administration Frequency and Incidence Rate of Hospitalization in Schizophrenia
- Association of Oral and Long-Acting Injectable Antipsychotic Administration Frequency With Odds of Hospitalization in Schizophrenia: Network Meta-Analysis of Cohort Studies