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  • ||||||||||  Uzedy (risperidone XR SC suspension) / Teva, MedinCell
    Journal:  TV-46000, A Long-Acting Subcutaneous Antipsychotic Agent, Demonstrated Improved Patient-Centered Outcomes in Patients with Schizophrenia. (Pubmed Central) -  Oct 14, 2024   
    P3
    Improvements in patient-centered outcomes were observed across cohorts, with the largest improvements observed for patients who began TV-46000 during SHINE (ie, de novo and placebo rollover cohorts), while gains made during RISE were minimally improved or maintained in the TV-46000 rollover cohort, indicating the benefit of uninterrupted TV-46000 treatment. These data support the effectiveness of TV-46000 to improve patient-centered outcomes in patients with schizophrenia.
  • ||||||||||  long-acting injectable ivermectin / MedinCell
    Does Ivermectin impair Anopheles attractiveness toward treated hosts under fields and laboratory conditions? (Convention Center - Room 353 (3rd Floor); In-Person-Only) -  Oct 11, 2024 - Abstract #ASTMH2024ASTMH_3372;    
    We showed an insecticidal effect for up to 3-4 months on major wild malaria vector, meeting the WHO target product profile for endectocide-based malaria control. Dual-choice experiments with wild mosquitoes may help concluding on potential attractiveness impairment by ivermectin treatments, from which disentangling parts of the princeps molecule and the vehicle will also be needed.
  • ||||||||||  long-acting injectable ivermectin / MedinCell
    Pharmacokinetic properties and mosquito-lethal effects of a novel long-lasting formulation of ivermectin in cattle (Convention Center - Hall I-1 (1st Floor); In-Person-Only) -  Oct 11, 2024 - Abstract #ASTMH2024ASTMH_3144;    
    Body weight-scaled doses used in cattle (0.6, 1, 1.5 mg/kg) were predicted to result in sustained ivermectin exposure and sustained dirus and minimus killing for >35 days and >90 days, respectively, after a single injection. This could be a promising novel tool for transmission blocking of malaria and for the treatment of NTDs in humans.
  • ||||||||||  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.
  • ||||||||||  long-acting injectable ivermectin / MedinCell
    Trial completion:  Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 (clinicaltrials.gov) -  Jun 22, 2021   
    P1,  N=24, Completed, 
    Formulations releasing these drugs have been administered to animal models to show the possibility of delivering therapeutics from weeks to months by using BEPO® technology. Recruiting --> Completed
  • ||||||||||  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