Lybalvi (olanzapine/samidorphan) / Alkermes 
Welcome,         Profile    Billing    Logout  
 1 Disease   4 Trials   4 Trials   263 News 


«1234»
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    [VIRTUAL] Olanzapine/Samidorphan Mitigates Weight Gain across Subgroups of Patients Known to Be at Increased Risk for Weight Gain with Olanzapine Treatment () -  Mar 1, 2021 - Abstract #SIRS2021SIRS_174;    
    Relative to olanzapine, the odds ratios (95% CI) for having a ≥10% weight gain from baseline at week 24 with OLZ/SAM treatment were 0.50 (0.31, 0.80) in the overall population, 0.41 (0.23, 0.73) for males, 0.68 (0.30, 1.55) for females, 0.65 (0.25, 1.70) for age <30 years, 0.46 (0.27, 0.78) for age ≥30 years, 0.47 (0.27, 0.82) for black patients, 0.55 (0.24, 1.30) for non-black patients, 0.57 (0.32, 1.00) with BMI <27 kg/m2, and 0.38 (0.16, 0.87) with BMI ≥27 kg/m2. Discussion In this exploratory analysis of the 24-week, phase 3 study of patients with schizophrenia, the combination OLZ/SAM treatment mitigated weight gain associated with olanzapine across several patient subgroups, including groups of patients who are known to be at higher risk for weight gain with olanzapine based on sex, race, age, and baseline BMI.
  • ||||||||||  olanzapine/samidorphan (ALKS 3831) / Alkermes
    PK/PD data, Journal:  Effect of Food on the Pharmacokinetics of a Combination of Olanzapine and Samidorphan. (Pubmed Central) -  Jul 31, 2020   
    Although the lower bound of the 90%CI for the fed/fasted ratio of SAM C (76%-94%) was slightly below the 80% equivalence limit, this slight decrease was not considered clinically meaningful. The results indicated that food does not have a clinically relevant impact on the PK of OLZ and SAM given as OLZ/SAM.
  • ||||||||||  olanzapine/samidorphan (ALKS 3831) / Alkermes, lithium / Generic mfg.
    Clinical, PK/PD data, Journal:  Combination of Olanzapine and Samidorphan Has No Clinically Significant Effect on the Pharmacokinetics of Lithium or Valproate. (Pubmed Central) -  Jun 4, 2020   
    Consistent with previously reported findings on olanzapine, administration of multiple doses of OLZ/SAM did not have a clinically significant effect on the pharmacokinetics of lithium or valproate. Co-administration of OLZ/SAM and lithium or valproate was generally well tolerated; the safety profile of OLZ/SAM was consistent with that observed in previous clinical studies.
  • ||||||||||  olanzapine/samidorphan (ALKS 3831) / Alkermes, samidorphan (ALKS 33) / Alkermes, olanzapine / Generic mfg.
    PK/PD data, Journal:  Effect of hepatic and renal impairment on the pharmacokinetics of olanzapine and samidorphan given in combination as a bilayer tablet. (Pubmed Central) -  Apr 26, 2020   
    Compared with healthy control subjects, subjects with severe renal impairment had a 33% and 56% reduction in clearance, a 1.51- and 2.31-fold increase in AUC, and a 1.32- and 1.37-fold increase in C of olanzapine and samidorphan, respectively. OLZ/SAM 5/10 mg was generally well tolerated under the conditions of the studies, with a safety profile consistent with that observed in other clinical studies of OLZ/SAM.
  • ||||||||||  metformin / Generic mfg., clozapine / Generic mfg.
    Review, Journal:  New discoveries for an old drug: A review of recent olanzapine research. (Pubmed Central) -  Feb 15, 2020   
    Olanzapine remains a useful antipsychotic albeit with careful monitoring. Further research is needed to compare the different options available to mitigate olanzapine-induced weight gain and to evaluate potential synergism between pharmacological and non-pharmacological treatments.
  • ||||||||||  olanzapine/samidorphan (ALKS 3831) / Alkermes
    A Combination of Olanzapine and Samidorphan has No Clinically Relevant Effect on QT Prolongation up to Supratherapeutic Doses (Floridian Ballroom) -  Oct 17, 2019 - Abstract #ACNP2019ACNP_782;    
    Metabolic parameter changes were generally small, similar between groups over 24 weeks, and remained stable over an additional 52 weeks of open-label OLZ/SAM treatment. OLZ/SAM, in doses and plasma concentrations up to supratherapeutic levels, was well tolerated and had no clinically relevant effects on electrocardiogram parameters, including QT interval, in patients with schizophrenia.
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Trial completion date, Trial primary completion date:  Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (clinicaltrials.gov) -  Aug 5, 2019   
    P3,  N=500, Enrolling by invitation, 
    Trial registration: Clinical trials NCT02161718, registered May 2014; EudraCT Number: 2014-001211-39. Trial completion date: Jan 2021 --> Dec 2022 | Trial primary completion date: Jan 2021 --> Dec 2022
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Enrollment closed, Enrollment change:  A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia (clinicaltrials.gov) -  Jan 23, 2019   
    P3,  N=266, Active, not recruiting, 
    Over the course of this 52 week study, there was a significant improvement in schizophrenia symptoms. Enrolling by invitation --> Active, not recruiting | N=540 --> 266
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Trial completion, Trial completion date, Trial primary completion date:  A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia (clinicaltrials.gov) -  Jul 27, 2018   
    P3,  N=281, Completed, 
    Trial completion date: Feb 2019 --> Nov 2019 | Trial primary completion date: Jan 2019 --> Oct 2019 Enrolling by invitation --> Completed | Trial completion date: Dec 2018 --> Jun 2018 | Trial primary completion date: Dec 2018 --> Jun 2018
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Trial primary completion date:  A Phase 3, Long-term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia (clinicaltrials.gov) -  Sep 18, 2017   
    P3,  N=540, Enrolling by invitation, 
    Enrolling by invitation --> Completed | Trial completion date: Dec 2018 --> Jun 2018 | Trial primary completion date: Dec 2018 --> Jun 2018 Trial primary completion date: Dec 2018 --> Aug 2019
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Trial primary completion date:  A Study of ALKS 3831 in Adults With Schizophrenia (The ENLIGHTEN-2 Study) (clinicaltrials.gov) -  Sep 6, 2017   
    P3,  N=540, Recruiting, 
    Trial primary completion date: Dec 2018 --> Aug 2019 Trial primary completion date: Feb 2018 --> Aug 2018
  • ||||||||||  Lybalvi (olanzapine/samidorphan) / Alkermes
    Trial completion, Enrollment change:  An Insulin Sensitivity Study in Healthy Subjects (clinicaltrials.gov) -  Aug 22, 2017   
    P1,  N=60, Completed, 
    Trial primary completion date: Feb 2018 --> Aug 2018 Recruiting --> Completed | N=50 --> 60