Effect of hepatic and renal impairment on the pharmacokinetics of olanzapine and samidorphan given in combination as a bilayer tablet

References

• Lehman AF, Lieberman JA, Dixon LB, et al. Practice Guideline for the Treatment of Patients with Schizophrenia. 2nded; 2010 Available from: https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/schizophrenia.pdf. Accessed 128, 2019.
   Google Scholar
• Agid O, Foussias G, Singh S, Remington G. Where to position clozapine: re-examining the evidence. Can J Psychiatry. 2010;55(10):677–684. doi:10.1177/07067437100550100720964947
   PubMed Web of Science ®Google Scholar
• Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet. 2013;382(9896):951–962. doi:10.1016/S0140-6736(13)60733-323810019
   PubMed Web of Science ®Google Scholar
• Tabarin A, Diz-Chaves Y, Carmona Mdel C, et al. Resistance to diet-induced obesity in mu-opioid receptor-deficient mice: evidence for a “thrifty gene”. Diabetes. 2005;54(12):3510–3516. doi:10.2337/diabetes.54.12.351016306369
   PubMed Web of Science ®Google Scholar
• Czyzyk TA, Romero-Pico A, Pintar J, et al. Mice lacking delta-opioid receptors resist the development of diet-induced obesity. Faseb J. 2012;26(8):3483–3492. doi:10.1096/fj.12-20804122593549
   PubMed Web of Science ®Google Scholar
• Czyzyk TA, Nogueiras R, Lockwood JF, et al. kappa-Opioid receptors control the metabolic response to a high-energy diet in mice. Faseb J. 2010;24(4):1151–1159. doi:10.1096/fj.09-14361019917675
   PubMed Web of Science ®Google Scholar
• Wentland MP, Lou R, Lu Q, et al. Syntheses of novel high affinity ligands for opioid receptors. Bioorg Med Chem Lett. 2009;19(8):2289–2294. doi:10.1016/j.bmcl.2009.02.07819282177
   PubMed Web of Science ®Google Scholar
• Bidlack JM, Knapp BI, Deaver DR, et al. In vitro pharmacological characterization of buprenorphine, samidorphan, and combinations being developed as an adjunctive treatment of major depressive disorder. J Pharmacol Exp Ther. 2018;367(2):267–281. doi:10.1124/jpet.118.24983930108159
   PubMed Web of Science ®Google Scholar
• Shram MJ, Silverman B, Ehrich E, Sellers EM, Turncliff R. Use of remifentanil in a novel clinical paradigm to characterize onset and duration of opioid blockade by samidorphan, a potent mu-receptor antagonist. J Clin Psychopharmacol. 2015;35(3):242–249. doi:10.1097/JCP.000000000000032025928699
   PubMed Web of Science ®Google Scholar
• Sun L, McDonnell D, Liu J, von Moltke L. Bioequivalence of olanzapine given in combination with samidorphan as a bilayer tablet (ALKS 3831) compared with olanzapine-alone tablets: results from a randomized, crossover relative bioavailability study. Clin Pharmacol Drug Dev. 2019;8(4):459–466. doi:10.1002/cpdd.60130059196
   PubMed Web of Science ®Google Scholar
• Silverman BL, Martin W, Memisoglu A, DiPetrillo L, Correll CU, Kane JM. A randomized, double-blind, placebo-controlled proof of concept study to evaluate samidorphan in the prevention of olanzapine-induced weight gain in healthy volunteers. Schizophr Res. 2018;195:245–251. doi:10.1016/j.schres.2017.10.01429158012
   PubMed Web of Science ®Google Scholar
• Martin WF, Correll CU, Weiden PJ, et al. Mitigation of olanzapine-induced weight gain with samidorphan, an opioid antagonist: a randomized double-blind phase 2 study in patients with schizophrenia. Am J Psychiatry. 2019;176(6):457–467. doi:10.1176/appi.ajp.2018.1803028030845818
   PubMed Web of Science ®Google Scholar
• Kassahun K, Mattiuz E, Nyhart E Jr, et al. Disposition and biotransformation of the antipsychotic agent olanzapine in humans. Drug Metab Dispos. 1997;25(1):81–93.9010634
   PubMed Web of Science ®Google Scholar
• Yuan R, Venitz J. Effect of chronic renal failure on the disposition of highly hepatically metabolized drugs. Int J Clin Pharmacol Ther. 2000;38(5):245–253. doi:10.5414/cpp3824510839468
   PubMed Web of Science ®Google Scholar
• Wagner C, Zhao P, Pan Y, et al. Application of physiologically based pharmacokinetic (PBPK) modeling to support dose selection: report of an FDA public workshop on PBPK. CPT Pharmacometrics Syst Pharmacol. 2015;4(4):226–230. doi:10.1002/psp4.3326225246
   PubMedGoogle Scholar
• Sun L, McDonnell D, von Moltke L. Pharmacokinetics and short-term safety of ALKS 3831, a fixed-dose combination of olanzapine and samidorphan, in adult subjects with schizophrenia. Clin Ther. 2018;40(11):1845–1854. doi:10.1016/j.clinthera.2018.09.00230348514
   PubMed Web of Science ®Google Scholar
• Callaghan JT, Bergstrom RF, Ptak LR, Beasley CM. Olanzapine. Pharmacokinetic and pharmacodynamic profile. Clin Pharmacokinet. 1999;37(3):177–193. doi:10.2165/00003088-199937030-0000110511917
   PubMed Web of Science ®Google Scholar
• Zyprexa (olanzapine) new drug approval package; 1996 Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020592_Original_Approval_Pkg%20.pdf. Accessed 926, 2018.
   Google Scholar
• Telles-Correia D, Barbosa A, Cortez-Pinto H, Campos C, Rocha NB, Machado S. Psychotropic drugs and liver disease: a critical review of pharmacokinetics and liver toxicity. World J Gastrointest Pharmacol Ther. 2017;8(1):26–38. doi:10.4292/wjgpt.v8.i1.2628217372
   PubMedGoogle Scholar
• US Food and Drug Administration. Guidance for industry pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling; 2003 Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-hepatic-function-study-design-data-analysis-and-impact-dosing-and. Accessed 78, 2019.
   Google Scholar
• US Food and Drug Administration. Guidance for industry: pharmacokinetics in patients with impaired renal function—study design, data analysis, and impact on dosing and labeling. Revision 1; 2010 Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pharmacokinetics-patients-impaired-renal-function-study-design-data-analysis-and-impact-dosing-and. Accessed 78, 2019.
   Google Scholar
• European Medicines Agency. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function; 2005 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-impaired-hepatic-function_en.pdf. Accessed 78, 2019.
   Google Scholar
• European Medicines Agency. Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function; 2015 Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-evaluation-pharmacokinetics-medicinal-products-patients-decreased-renal-function_en.pdf. Accessed: 78, 2019.
   Google Scholar
• Ibrahim S, Honig P, Huang SM, Gillespie W, Lesko LJ, Williams RL. Clinical pharmacology studies in patients with renal impairment: past experience and regulatory perspectives. J Clin Pharmacol. 2000;40(1):31–38.10631619
   PubMed Web of Science ®Google Scholar
• Markowitz JS, DeVane CL, Boulton DW, Liston HL, Risch SC. Hypotension and bradycardia in a healthy volunteer following a single 5 mg dose of olanzapine. J Clin Pharmacol. 2002;42(1):104–106.11808820
   PubMed Web of Science ®Google Scholar