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- | Lybalvi (olanzapine/samidorphan) / Alkermes
Journal, Real-world evidence, Real-world: Treating Schizophrenia and Bipolar I Disorder in the Real-World Setting: Effectiveness and Safety of Olanzapine/Samidorphan Combination. (Pubmed Central) - Apr 9, 2024
No abstract available
- | lithium carbonate ER / Generic mfg.
Journal: Drugs for bipolar disorder. (Pubmed Central) - Apr 9, 2024
No abstract available No abstract available
- Lybalvi (olanzapine/samidorphan) / Alkermes
Health care resource utilization following 6 months of treatment with olanzapine/ samidorphan: Real-world assessment of patients with schizophrenia or bipolar I disorder () - Apr 9, 2024 - Abstract #AMCP2024AMCP_99;
This is the first real-world study to assess HCRU 6 months before and after OLZ/SAM initiation. Among patients with SZ or BD-I, OLZ/SAM initiation was associated with significant reductions in the proportions of patients with all-cause and mental health
- Lybalvi (olanzapine/samidorphan) / Alkermes
Healthcare Resource Utilization Following 6 Months of Treatment With Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia or Bipolar I Disorder (National BCD) - Mar 25, 2024 - Abstract #AAPP2024AAPP_153;
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Retrospective data, Review, Journal: Olanzapine-Samidorphan for Schizophrenia: A Systematic Review and Meta-Analysis. (Pubmed Central) - Mar 25, 2024
Drug discontinuation incidence was higher in the OLZSAM group: RR = 1.22; 95% CI = 0.84-1.79; p = 0.30. The combination OLZSAM showed comparable efficacy to olanzapine alone in schizophrenia patients, with relatively less incidence of weight gain and adverse events; however, the drug discontinuation due to adverse events was more in the OLZSAM group.
- Lybalvi (olanzapine/samidorphan) / Alkermes
Healthcare Resource Utilization Following 6 Months of Treatment With Olanzapine/Samidorphan: Real-World Assessment of Patients With Schizophrenia or Bipolar I Disorder () - Mar 8, 2024 - Abstract #ISPOR2024ISPOR_436;
The combination OLZSAM showed comparable efficacy to olanzapine alone in schizophrenia patients, with relatively less incidence of weight gain and adverse events; however, the drug discontinuation due to adverse events was more in the OLZSAM group. Among patients with SZ or BD-I, real-world OLZ/SAM initiation was associated with significant reductions in proportions of patients with all-cause and mental health
- || iloperidone / Generic mfg.
Review, Journal, Real-world evidence, Real-world effectiveness, Real-world: A systematic review of the real-world effectiveness and economic and humanistic outcomes of selected oral antipsychotics among patients with schizophrenia in the United States: Updating the evidence and gaps. (Pubmed Central) - Feb 3, 2024
Our findings also suggest an unmet need regarding treatment nonadherence and lack of persistence among patients receiving OATs. We identified a need for research addressing OATs' behavioral and humanistic outcomes and evaluating the impact of product switching in adults with schizophrenia in the United States, which could assist clinicians in promoting patient-centered care and help payers understand the total value of new antipsychotic drugs.
- |||| Lybalvi (olanzapine/samidorphan) / Alkermes
Trial completion date, Trial primary completion date: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (clinicaltrials.gov) - Dec 15, 2023
P3, N=220, Recruiting, Sponsor: Alkermes, Inc.
- NaBen (sodium benzoate) / SyneuRx, Lybalvi (olanzapine/samidorphan) / Alkermes, ulotaront (SEP-363856) / Sumitomo Pharma, Otsuka, PsychoGenics
A Quest for Treatment Discovery in Children and Adolescents With Schizophrenia: Investigational Drugs in Pipeline (Sutton North (New York Hilton Midtown); In-person) - Sep 30, 2023 - Abstract #AACAP2023AACAP_772;
Conclusions New drug development in schizophrenia is on the horizon. The clinicians are excited and optimistic with the treatment advances, and this presentation will make them familiar with the molecules in development.
- The Drug Hunt: An Exploration of New Medications for Treatment of Schizophrenia in Children and Adolescents (Sutton North (New York Hilton Midtown); In-person) - Sep 30, 2023 - Abstract #AACAP2023AACAP_771;
An update on cutting-edge evidence on treatment developments in schizophrenia is vital to inform the pediatric prescription practices. The scope of the ongoing studies to bring novel pharmacological evidence to clinical practice will serve to be beneficial for clinicians treating children and adolescents with schizophrenia.
- Clinical Perspectives 51 : Novel Treatments on the Horizon: A Glimpse Into the Newer Pharmacological Treatments Under Investigation for the Treatment of Schizophrenia in Pediatric Patients (Sutton North (New York Hilton Midtown); In-person) - Sep 30, 2023 - Abstract #AACAP2023AACAP_770;
Conclusions Current treatment for schizophrenia in adolescents is limited and demands a vital need for newer pharmacological agents. This presentation will review the cutting-edge evidence on novel investigational agents and offer insight into the upcoming psychopharmacological evidence for treatment of schizophrenia in pediatric population.
- Lybalvi (olanzapine/samidorphan) / Alkermes
Olanzapine/Samidorphan Effects on Weight Gain: A Pooled Analysis of Phase 2 and 3 Randomized, Double-Blind Studies (Salon 4) - Apr 15, 2023 - Abstract #ASCP2023ASCP_212;
P2, P3
Baseline mean (SD) age was 35.2 (10.7), 308 (29%) were female, 440 (41.4%) were White, and mean (SD) body mass index (BMI) was 24.8 (3.3) kg/m2. At week 12, OLZ/SAM treatment was associated with a lower least-square mean (LSM) percent change in body weight from baseline (3.68%) vs olanzapine (5.43%) (LSM [SE] difference=-1.75% [0.41]; 95% CI=-2.55, -0.94).
- Lybalvi (olanzapine/samidorphan) / Alkermes
Long-term Retrospective Study of Weight Change in Cannabis Positive Outpatients with Schizophrenia or Bipolar 1 Disorder receiving treatment with Olanzapine/samidorphan vs Olanzapine Alone. (Grand Hall West) - Apr 2, 2023 - Abstract #AAPP2023AAPP_209;
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, Journal: Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who Are Early in Their Illness: Results of the Randomized, Controlled ENLIGHTEN-Early Study. (Pubmed Central) - Mar 25, 2023
P3
In patients with early-phase schizophrenia, schizophreniform disorder, or BD-I, OLZ/SAM treatment resulted in less weight gain versus olanzapine. Trial Registration: ClinicalTrials.gov identifier: NCT03187769.
- ||| Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
P3 data, Retrospective data, Journal: Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study. (Pubmed Central) - Mar 20, 2023
P3
OLZ/SAM treatment was associated with lower risk of worsening cardiometabolic risk factors related to obesity, hypertension, and metabolic syndrome relative to olanzapine. NCT02694328, https://clinicaltrials.gov/ct2/show/NCT02694328.
- Lybalvi (olanzapine/samidorphan) / Alkermes
Economic Impact of Discontinuation and Relapse Rates Among Patients with Schizophrenia Newly Initiated on Lybalvi Versus Olanzapine during First Year Use () - Mar 9, 2023 - Abstract #ISPOR2023ISPOR_172;
NCT02694328, https://clinicaltrials.gov/ct2/show/NCT02694328. During 2021, the US Food and Drug Administration approved a combination of OLZ and samidorphan (OLZ/SAM [LYBALVI
- | Lybalvi (olanzapine/samidorphan) / Alkermes
Journal: A Case of Opioid Withdrawal Precipitated by Samidorphan / Olanzapine in a Patient Taking Buprenorphine / Naloxone. (Pubmed Central) - Feb 12, 2023
During 2021, the US Food and Drug Administration approved a combination of OLZ and samidorphan (OLZ/SAM [LYBALVI No abstract available
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Trial completion, Trial completion date, Trial primary completion date: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan (clinicaltrials.gov) - Feb 10, 2023
P1, N=12, Completed, Sponsor: Alkermes, Inc.
No abstract available Recruiting --> Completed | Trial completion date: Jul 2023 --> Nov 2022 | Trial primary completion date: Jul 2023 --> Nov 2022
- | Lybalvi (olanzapine/samidorphan) / Alkermes
Journal: The Facts and Fiction of Olanzapine-Samidorphan Fixed Dose Combination. (Pubmed Central) - Nov 26, 2022
Recruiting --> Completed | Trial completion date: Jul 2023 --> Nov 2022 | Trial primary completion date: Jul 2023 --> Nov 2022 No abstract available
- | samidorphan (ALKS 33) / Alkermes
Preclinical, Journal: In vivo Characterization of the Opioid Receptor-Binding Profiles of Samidorphan and Naltrexone in Rats: Comparisons at Clinically Relevant Concentrations. (Pubmed Central) - Nov 9, 2022
The atypical antipsychotic olanzapine is approved for the treatment of schizophrenia and bipolar I disorder; however, weight gain and metabolic dysregulation associated with olanzapine therapy have limited its clinical utility...At clinically relevant concentrations, samidorphan occupied MOR, DOR, and KOR, whereas naltrexone occupied only MOR and KOR. The binding profile of samidorphan differs from that of naltrexone, with potential clinical implications.
- Lybalvi (olanzapine/samidorphan) / Alkermes
Olanzapine/Samidorphan in Young Adults With Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder Who are Early in Illness: Results of the Enlighten-Early Study () - Oct 31, 2022 - Abstract #ACNP2022ACNP_261;
P3
The binding profile of samidorphan differs from that of naltrexone, with potential clinical implications. Treatment with OLZ/SAM mitigated weight gain vs olanzapine in early-in-illness patients with schizophrenia, schizophreniform disorder, or BD-I.
- || Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
Clinical, Journal: Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients. (Pubmed Central) - Oct 14, 2022
P3
Treatment with OLZ/SAM mitigated weight gain vs olanzapine in early-in-illness patients with schizophrenia, schizophreniform disorder, or BD-I. In these exploratory subgroup analyses from the ENLIGHTEN-2 study, weight-mitigating effects of OLZ/SAM vs olanzapine were observed consistently across patient subgroups and were in line with results from the overall study population.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Enrollment open: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan (clinicaltrials.gov) - Oct 10, 2022
P1, N=12, Recruiting, Sponsor: Alkermes, Inc.
In these exploratory subgroup analyses from the ENLIGHTEN-2 study, weight-mitigating effects of OLZ/SAM vs olanzapine were observed consistently across patient subgroups and were in line with results from the overall study population. Not yet recruiting --> Recruiting
- | samidorphan (ALKS 33) / Alkermes
Journal: Samidorphan for the treatment of weight gain associated with olanzapine in patients with schizophrenia and bipolar disorder. (Pubmed Central) - Sep 24, 2022
OLZ/SAM was well tolerated. Therefore, it is a potential new treatment option for schizophrenia.
- Novel Antipsychotics and Risk of Drug-Induced Movement Disorders and Tardive Syndromes (Poster Station: 21) - Sep 22, 2022 - Abstract #MDSCongress2022MDR_Congress_501;
Compared to oral paliperidone, the LAI may decrease risk of DIMDs while LAI risperidone and aripiprazole have equal risk compared to oral formulations. Furthermore, new experimental drug targets that do not use dopamine receptor blockade show promise in reducing incidence of DIMDs.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
New P1 trial: Study of the Breast Milk Pharmacokinetics of Olanzapine and Samidorphan (clinicaltrials.gov) - Sep 21, 2022
P1, N=12, Not yet recruiting, Sponsor: Alkermes, Inc.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, Review, Journal: Olanzapine/Samidorphan: A New Option for the Treatment of Adults With Schizophrenia or Bipolar I Disorder. (Pubmed Central) - Sep 3, 2022
Advantages of this drug combination include once-daily dosing, favorable tolerability, and most importantly, mitigation of weight gain, which may encourage adherence, when compared with OLZ alone. The new combination treatment of OLZ/SAM is a unique antipsychotic formulation to provide the recognized efficacious treatment of OLZ, while mitigating the weight gain and possibly the weight-related adverse effects secondary to OLZ monotherapy.
- | Lybalvi (olanzapine/samidorphan) / Alkermes
Journal: Olanzapine/Samidorphan: New Drug Approved for Treating Bipolar I Disorder and Schizophrenia. (Pubmed Central) - Jul 28, 2022
When treating complex patients with schizophrenia, the olanzapine/samidorphan combination has limited effect on medication-induced weight gain often associated with antipsychotic olanzapine monotherapy. Additional studies are needed to further define the role of olanzapine/samidorphan in bipolar I disorder and clinical practice.
- ||| Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
Review, Journal, Adverse events, Combination therapy: Samidorphan/olanzapine combination therapy for schizophrenia: Efficacy, tolerance and adverse outcomes of regimen, evidence-based review of clinical trials. (Pubmed Central) - Jul 23, 2022
The FDA-approved drug recombination of OLZ/SAM for the treatment of schizophrenia revealed efficacious outcomes and was generally well tolerated by patients partaking in various trials. The potential of samidorphan in mimicking the efficacy of olanzapine while mitigating olanzapine-induced weight gain makes it a promising regimen for improving symptoms and health outcomes in schizophrenic patients.
- | Lybalvi (olanzapine/samidorphan) / Alkermes
Journal: Olanzapine/samidorphan precipitated opioid withdrawal in a patient taking transdermal fentanyl. (Pubmed Central) - Jul 10, 2022
The potential of samidorphan in mimicking the efficacy of olanzapine while mitigating olanzapine-induced weight gain makes it a promising regimen for improving symptoms and health outcomes in schizophrenic patients. No abstract available
- |||||| Lybalvi (olanzapine/samidorphan) / Alkermes
Enrollment open: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (clinicaltrials.gov) - Jul 8, 2022
P3, N=220, Recruiting, Sponsor: Alkermes, Inc.
No abstract available Not yet recruiting --> Recruiting
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Review, Journal: Combination Olanzapine and Samidorphan for the Management of Schizophrenia and Bipolar 1 Disorder in Adults: A Narrative Review. (Pubmed Central) - Jul 2, 2022
Clinical trial patients reported improvements in symptoms of psychosis, reduced weight gain, and overall satisfaction with their treatment. OLZ/SAM has been as shown to be a safe and effective pharmaceutical option for the clinical management of schizophrenia and B1D.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Review, Journal: Olanzapine/Samidorphan: A New Combination Treatment for Schizophrenia and Bipolar I Disorder Intended to Reduce Weight Gain. (Pubmed Central) - Jun 11, 2022
Weight gain and metabolic side effects associated with olanzapine monotherapy can result in tolerability issues and potentially medication nonadherence. Olanzapine/samidorphan is an effective treatment for schizophrenia and bipolar I disorder with less weight gain than olanzapine monotherapy.
- | Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
Journal: Olanzapine-samidorphan combination tablets for the treatment of schizophrenia and bipolar I disorder - what is it, and will it be used? (Pubmed Central) - May 22, 2022
It has a limited effect on metabolic laboratory parameters and cumulatively tends to limit weight gain rather than promote weight loss. Additional research will be needed to determine its effectiveness compared to alternative strategies to attenuate antipsychotic induced weight gain.
- Lybalvi (olanzapine/samidorphan) / Alkermes
Olanzapine/Samidorphan in Young Adults with Schizophrenia, Schizophreniform Disorder, or Bipolar I Disorder who Are Early in Their Illness: Results of the Enlighten-Early Study (Princess Ballroom I) - May 6, 2022 - Abstract #ASCP2022ASCP_50;
P3
At week 12, OLZ/SAM treatment was associated with a significantly lower percent weight change from baseline (4.91%) vs olanzapine (6.77%): least squares (LS) mean (SE) difference=−1.87% (0.745), P=0.012. Fewer patients in the OLZ/SAM vs the olanzapine group gained ≥10% of baseline body weight (21.9% vs 30.4%; OR=0.64, 95% CI=0.39, 1.05) or ≥7% of baseline body weight (33.1% vs 44.8%; OR=0.61, 95% CI=0.39, 0.94).
- Lybalvi (olanzapine/samidorphan) / Alkermes, Caplyta (lumateperone) - Intra / Cellular Therapies
8211: Clinical Update on Managing Schizophrenia: Drugs and Other Treatments ([VIRTUAL]) - May 5, 2022 - Abstract #APA2022APA_1136;
The clinical implications of new research on non-pharmacologic somatic treatments including aerobic exercise, transcranial magnetic stimulation, and electroconvulsive therapy will be discussed. Finally, there will be a discussion of new drugs for schizophrenia that are in Phase 3 trials.
- || olanzapine / Generic mfg.
PK/PD data, Journal: Pharmacokinetic-Pharmacodynamic Analysis of Concentration-Response Relationship in Schizophrenia Patients Treated with Olanzapine or OLZ/SAM. (Pubmed Central) - May 5, 2022
Furthermore, olanzapine-associated weight gain did not correlate with olanzapine dose or plasma concentration. Finally, the effect of OLZ/SAM on mitigation of olanzapine-associated weight gain was not affected by intersubject variability in olanzapine and/or samidorphan plasma concentrations.
- | Lybalvi (olanzapine/samidorphan) / Alkermes
Journal, Benefit-risk assessment: A Structured Benefit-Risk Assessment to Evaluate a Combination of Olanzapine and Samidorphan for the Treatment of Schizophrenia and Bipolar I Disorder. (Pubmed Central) - May 5, 2022
Based on this assessment, OLZ/SAM has comparable efficacy and a safety profile consistent with olanzapine, with reduced weight gain. A structured approach to assessing the benefit-risk profile of a product facilitates transparent evaluation and communication.
- || Review, Journal: Existing and emerging pharmacological approaches to the treatment of mania: A critical overview. (Pubmed Central) - Apr 26, 2022
As for the emerging experimental antipsychotic, some of them (including KarXT, SEP-363856, RO6889450, ALKS3831) have demonstrated good antipsychotic efficacy and a favorable safety profile, but little is known about their use in patients with bipolar disorder and specifically designed trials are needed. Lastly, some benefits for the treatment of mania could be expected to come in the next future from non-mood stabilizers/non-antipsychotic agents (especially PKC inhibitors like Endoxifen): long-term trials are needed to confirm positive results in terms of long-term efficacy and safety.
- | Lybalvi (olanzapine/samidorphan) / Alkermes
Journal: Spectrofluorimetric first derivative synchronous approach for determination of olanzapine and samidorphan used for treatment of schizophrenia in pharmaceutical formulations and human plasma. (Pubmed Central) - Apr 12, 2022
The devised approach was effectively used to the quantitative measurement of the two medicines in Lybalvi® tablets with various samidorphan and olanzapine ratios, in addition to spiked human plasma. A variance ratio F-test and student t-test were needed to be able to compare the results to another published analytical technique and found no significant differences.
- |||||||||| Lybalvi (olanzapine/samidorphan) / Alkermes
New P3 trial: Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder (clinicaltrials.gov) - Mar 31, 2022
P3, N=220, Not yet recruiting, Sponsor: Alkermes, Inc.
- Lybalvi (olanzapine/samidorphan) / Alkermes
A Structured Benefit-Risk Assessment to Evaluate a Combination of Olanzapine and Samidorphan for the Treatment of Schizophrenia and Bipolar I Disorder () - Mar 11, 2022 - Abstract #SIRS2022SIRS_946;
In ENLIGHTEN-2, OLZ/SAM had reduced risks of weight gain and waist circumference increases compared with olanzapine, along with similar risks of relapse and psychiatric discontinuation and no difference in metabolic worsening, neutropenia, hyperprolactinemia, orthostatic hypotension, sedation, and movement disorders. Based on this assessment, OLZ/SAM has comparable efficacy and a safety profile consistent with olanzapine, with reduced weight gain.
- Lybalvi (olanzapine/samidorphan) / Alkermes
Budget Impact of LYBALVI® for the Treatment of Schizophrenia and Bipolar I Disorder from a US Payer Perspective (In-person & Virtual) - Mar 8, 2022 - Abstract #ISPOR2022ISPOR_558;
In hypothetical Commercial, Medicaid, and Medicare plans in the US, LYBALVI is estimated to have no additional costs to plans’ budgets. LYBALVI offers a new treatment option for patients living with these chronic and serious mental health conditions, without additional cost.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Review, Journal: Olanzapine and Samidorphan Combination Treatment: A Systematic Review. (Pubmed Central) - Mar 8, 2022
OLZ/SAM-treatment is associated with mitigated weight-gain liability when compared to OLZ-monotherapy in adults with schizophrenia. Additional studies are needed to ascertain patient acceptability, appropriate selection and sequencing of OLZ/SAM in the treatment algorithms for adults with schizophrenia (and BD-I), as well as to determine cost-effectiveness and long-term metabolic effects.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, P1 data, Journal: Insulin and glucose metabolism with olanzapine and a combination of olanzapine and samidorphan: exploratory phase 1 results in healthy volunteers. (Pubmed Central) - Mar 3, 2022
OLZ/SAM appeared to mitigate some of olanzapine's unfavorable postprandial metabolic effects (e.g., hyperinsulinemia, elevated C-peptide) in this exploratory study. These findings supplement the body of evidence from completed or ongoing OLZ/SAM clinical trials supporting its role in the treatment of schizophrenia and bipolar I disorder.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, PK/PD data, Journal: Population Pharmacokinetics of Olanzapine and Samidorphan When Administered in Combination in Healthy Subjects and Patients With Schizophrenia. (Pubmed Central) - Feb 17, 2022
Consistent with the known metabolic pathways for olanzapine (primarily via uridine 5'-diphospho-glucuronosyltransferase [UGT]-mediated direct glucuronidation and cytochrome P450 [CYP]-mediated oxidation) and for samidorphan (predominately mediated by CYP3A4), coadministration of OLZ/SAM with rifampin, a strong inducer of CYP3A4 and an inducer of UGT enzymes, significantly decreased the systemic exposure of both olanzapine and samidorphan. Severe renal impairment or moderate hepatic impairment resulted in modest increase in olanzapine and samidorphan exposure.
- ||||| Lybalvi (olanzapine/samidorphan) / Alkermes
Enrollment closed: Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831 (clinicaltrials.gov) - Feb 11, 2022
P3, N=500, Active, not recruiting, Sponsor: Alkermes, Inc.
Severe renal impairment or moderate hepatic impairment resulted in modest increase in olanzapine and samidorphan exposure. Enrolling by invitation --> Active, not recruiting
- | Lybalvi (olanzapine/samidorphan) / Alkermes, samidorphan (ALKS 33) / Alkermes
Journal: Olanzapine/samidorphan (Lybalvi) for schizophrenia and bipolar disorder. (Pubmed Central) - Feb 8, 2022
Enrolling by invitation --> Active, not recruiting No abstract available
- || Lybalvi (olanzapine/samidorphan) / Alkermes
PK/PD data, Journal: Using Physiologically Based Pharmacokinetic Modeling for Predicting the Effects of Hepatic Impairment on the Pharmacokinetics of Olanzapine and Samidorphan Given as a Combination Tablet. (Pubmed Central) - Feb 1, 2022
In applying the optimized model, mild, moderate, and severe hepatic impairment were predicted to increase steady-state total exposures by 1.1-, 1.5-, and 1.6-fold, respectively, for olanzapine, and by 1.2-, 1.9-, and 2.3-fold, respectively, for samidorphan. PBPK modeling allowed for prediction of untested clinical scenarios of varying degrees of hepatic impairment in lieu of additional clinical studies.
- || Lybalvi (olanzapine/samidorphan) / Alkermes
Clinical, Journal: Long-Term Safety and Durability of Effect With a Combination of Olanzapine and Samidorphan in Patients With Schizophrenia: Results From a 1-Year Open-Label Extension Study. (Pubmed Central) - Jan 11, 2022
PBPK modeling allowed for prediction of untested clinical scenarios of varying degrees of hepatic impairment in lieu of additional clinical studies. No abstract available