Uzedy (risperidone XR SC suspension) / Teva, MedinCell 
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  • ||||||||||  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:  Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia (clinicaltrials.gov) -  Dec 21, 2020   
    P3,  N=863, Completed, 
    The flexibility of the q1m and q2m sc dosing regimens has the potential to significantly improve patient compliance and acceptance of risperidone treatment, both of which are essential for the treatment of schizophrenia. Active, not recruiting --> Completed
  • ||||||||||  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
    Trial completion date, Trial primary completion date:  Study to Evaluate TV-46000 as Maintenance Treatment in Adult and Adolescent Participants With Schizophrenia (clinicaltrials.gov) -  Sep 30, 2020   
    P3,  N=863, Active, not recruiting, 
    Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Dec 2021 Trial completion date: Oct 2020 --> Jan 2021 | Trial primary completion date: Aug 2020 --> Nov 2020
  • ||||||||||  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
  • ||||||||||  Uzedy (risperidone XR SC suspension) / Teva, MedinCell
    Enrollment open:  A Study to Test if TV-46000 is Safe for Maintenance Treatment of Schizophrenia (clinicaltrials.gov) -  Jun 4, 2019   
    P3,  N=300, Recruiting, 
    Trial completion date: Apr 2020 --> Oct 2020 | Trial primary completion date: Jan 2020 --> Aug 2020 Not yet recruiting --> Recruiting