- |||||||||| Uzedy (risperidone XR SC suspension) / Teva, MedinCell
Journal: Efficacy and safety of TV-46000, a long-acting, subcutaneous, injectable formulation of risperidone, for schizophrenia: a randomised clinical trial in the USA and Bulgaria. (Pubmed Central) - Nov 20, 2023 P3 In patients with schizophrenia, subcutaneous TV-46000 once monthly and once every 2 months significantly delayed impending relapse versus placebo. TV-46000 is an effective long-acting, subcutaneous, antipsychotic agent treatment option in adult patients with schizophrenia, with a favourable benefit-risk profile.
- |||||||||| risperidone XR SC suspension (TV-46000) / Teva, MedinCell
PK/PD data, Journal: Population Pharmacokinetic Modeling and Simulation of TV-46000: A Long-Acting Injectable Formulation of Risperidone. (Pubmed Central) - Jul 6, 2022 The simulations showed that therapeutic dose ranges for TV-46000 are 50 to 125 mg for once-monthly and 100 to 250 mg for the once every 2 months regimens. This PPK model provided a basis for prediction of patient-specific exposure and dopamine-D2 receptor occupancy estimates to support further clinical development and dose selection for the phase 3 studies.
- |||||||||| Uzedy (risperidone XR SC suspension) / Teva, MedinCell
Trial completion: A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia (clinicaltrials.gov) - Jan 11, 2022 P3, N=336, Completed, This PPK model provided a basis for prediction of patient-specific exposure and dopamine-D2 receptor occupancy estimates to support further clinical development and dose selection for the phase 3 studies. Active, not recruiting --> Completed
- |||||||||| Doria (risperidone extended release) / ROVI Pharmaceuticals Laboratories, risperidone controlled-release implant (BB-0817) / Braeburn, Perseris (risperidone sustained-release 1-month depot) / Indivior, Reckitt Benckiser, HLS Therap
Review, Journal: Newer Formulations of Risperidone: Role in the Management of Psychotic Disorders. (Pubmed Central) - Aug 20, 2021 All three preparations have been shown to be effective and well tolerated in clinical trials. A fourth formulation (TV-46000), which can be given subcutaneously every 1 or 2 months, has recently begun trials.
- |||||||||| Uzedy (risperidone XR SC suspension) / Teva, MedinCell
Trial completion date, Trial primary completion date: A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia (clinicaltrials.gov) - Nov 30, 2020 P3, N=300, Recruiting, Active, not recruiting --> Completed Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Dec 2021
- |||||||||| Uzedy (risperidone XR SC suspension) / Teva, MedinCell
Enrollment closed, Enrollment change: Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia (clinicaltrials.gov) - May 11, 2020 P3, N=863, Active, not recruiting, Thus, additional mechanisms of action and agents require study to improve schizophrenia outcomes for total/positive symptoms with reduced adverse effects, but also cognitive symptoms, negative symptoms, and treatment resistance, the areas of greatest need in schizophrenia currently. Recruiting --> Active, not recruiting | N=596 --> 863
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