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Drug Profile

Samidorphan for the treatment of weight gain associated with olanzapine in patients with schizophrenia and bipolar disorder

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Pages 1011-1016 | Received 19 Jul 2021, Accepted 22 Aug 2022, Published online: 30 Aug 2022

References

  • Wt CsJr, Buchanan RW. Schizophrenia. N Engl J Med. 1994;330(10):681–690.
  • Owen MJ, Sawa A, Mortensen PB. Schizophrenia. Lancet. 2016;388(10039):86–97.
  • Takahashi M, Nakahara N, Fujikoshi S, et al. Remission, response, and relapse rates in patients with acute schizophrenia treated with olanzapine monotherapy or other atypical antipsychotic monotherapy: 12-month prospective observational study. Pragmat Obs Res. 2015 Jul 14;6: 39–46.
  • Faulkner G, Cohn TA. Pharmacologic and nonpharmacologic strategies for weight gain and metabolic disturbance in patients treated with antipsychotic medications [published correction appears in Can] Can J Psychiatry. 2006 Aug;51(9):620]. Can J Psychiatry. 2006;51(8):502–511.
  • Choi YJ. Efficacy of adjunctive treatments added to olanzapine or clozapine for weight control in patients with schizophrenia: a systematic review and meta-analysis. Sci World J. 2015;2015:970730.
  • Ren J, Zhang C. Rethinking olanzapine therapy for schizophrenia [published online ahead of print, 2021 Jun 26]. Asian J Psychiatr. 2021;62:102741.
  • Bak M, Fransen A, Janssen J, et al. Almost all antipsychotics result in weight gain: a meta-analysis. Plos One. 2014;9(4):e94112.
  • Maric NP, Jovicic MJ, Mihaljevic M, et al. Improving current treatments for schizophrenia. Drug Dev Res. 2016;77(7):357–367.
  • Ventriglio A, Bellomo A, Ricci F, et al. New pharmacological targets for the treatment of schizophrenia: a literature review [published online ahead of print, 2021 Jun 30]. Curr Top Med Chem. 2021;10(2174/1568026621666210701103147). DOI:10.2174/1568026621666210701103147
  • U.S. Food and drug administration. LYBALVI™ (olanzapine and samidorphan) tablets, for oral use. [cited 2021 Jun 21]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213378s000lbl.pdf.
  • Paik J. Olanzapine/samidorphan: first approval. Drugs. 2021;81(12):1431–1436.
  • Buchanan RW. How much of an advance is the addition of samidorphan to olanzapine? Am J Psychiatry. 2020;177(12):1113–1114.
  • Srisurapanont M, Suttajit S, Likhitsathian S, et al. A meta-analysis comparing short-term weight and cardiometabolic changes between olanzapine/samidorphan and olanzapine. Sci Rep. 2021;11(1):7583.
  • Atmaca M, Kuloglu M, Tezcan E, et al. Nizatidine treatment and its relationship with leptin levels in patients with olanzapine-induced weight gain. Hum Psychopharmacol. 2003;18(6):457–461.
  • Atmaca M, Kuloglu M, Tezcan E, et al. Nizatidine for the treatment of patients with quetiapine-induced weight gain. Hum Psychopharmacol. 2004;19(1):37–40.
  • Cavazzoni P, Tanaka Y, Roychowdhury SM, et al. Nizatidine for prevention of weight gain with olanzapine: a double-blind placebo-controlled trial. Eur Neuropsychopharmacol. 2003;13(2):81–85.
  • Deberdt W, Winokur A, Cavazzoni PA, et al. Amantadine for weight gain associated with olanzapine treatment. Eur Neuropsychopharmacol. 2005;15(1):13–21.
  • Ko YH, Joe SH, Jung IK, et al. Topiramate as an adjuvant treatment with atypical antipsychotics in schizophrenic patients experiencing weight gain. Clin Neuropharmacol. 2005;28(4):169–175.
  • Morrison JA, Cottingham EM, Barton BA. Metformin for weight loss in pediatric patients taking psychotropic drugs. Am J Psychiatry. 2002;159(4):655–657.
  • Seufert J, Lübben G, Dietrich K, et al. A comparison of the effects of thiazolidinediones and metformin on metabolic control in patients with type 2 diabetes mellitus. Clin Ther. 2004;26(6):805–818.
  • Wiernsperger NF, Bailey CJ. The antihyperglycaemic effect of metformin: therapeutic and cellular mechanisms. Drugs. 1999;58(1):31–82.
  • Bushe CJ, Bradley AJ, Doshi S, et al. Changes in weight and metabolic parameters during treatment with antipsychotics and metformin: do the data inform as to potential guideline development? A systematic review of clinical studies. Int J Clin Pract. 2009;63(12):1743–1761.
  • Praharaj SK, Jana AK, Goyal N, et al. Metformin for olanzapine-induced weight gain: a systematic review and meta-analysis. Br J Clin Pharmacol. 2011;71(3):377–382.
  • Yildiz A, Nikodem M, Vieta E, et al. A network meta-analysis on comparative efficacy and all-cause discontinuation of antimanic treatments in acute bipolar mania. Psychol Med. 2015;45(2):299–317.
  • Czyzyk TA, Romero-Picó A, Pintar J, et al. Mice lacking δ-opioid receptors resist the development of diet-induced obesity. FASEB J. 2012;26(8):3483–3492.
  • 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.
  • 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.
  • Marczak ED, Jinsmaa Y, Myers PH, et al. Orally administered H-Dmt-Tic-Lys-NH-CH2-Ph (MZ-2), a potent mu/delta-opioid receptor antagonist, regulates obese-related factors in mice. Eur J Pharmacol. 2009;616(1–3):115–121.
  • 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” [published correction appears in diabetes. 2006 Feb;55(2):563. Chaves, yolanda diz [corrected to Diz-Chaves, Y]] [published correction appears in diabetes. 2006 Mar;55(3):862]. Diabetes. 2005;54(12):3510–3516.
  • 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.
  • Chaudhary AMD, Khan MF, Dhillon SS, et al. A review of samidorphan: a novel opioid antagonist. Cureus. 2019;11(7):e5139.
  • Turncliff R, DiPetrillo L, Silverman B, et al. Single- and multiple-dose pharmacokinetics of samidorphan, a novel opioid antagonist, in healthy volunteers. Clin Ther. 2015;37(2):338–348.
  • Kumar V, Lu H, Hard M, et al. Characterization of the pharmacokinetics of samidorphan in healthy volunteers: absolute bioavailability and the effect of food and age. Drugs R D. 2019;19(3):277–287.
  • 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.e2.
  • Silverman BL, Martin W, Memisoglu A, et al. 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.
  • Sun L, Mills R, Sadler BM, et al. Population pharmacokinetics of olanzapine and samidorphan when administered in combination in healthy subjects and patients with schizophrenia. J Clin Pharmacol. 2021 May 21. DOI:10.1002/jcph.1911.
  • Sun L, McDonnell D, Yu M, et al. A phase I open-label study to evaluate the effects of rifampin on the pharmacokinetics of olanzapine and samidorphan administered in combination in healthy human subjects. Clin Drug Investig. 2019;39(5):477–484.
  • Sun L, Yagoda S, Yao B, et al. Combination of olanzapine and samidorphan has no clinically significant effect on the pharmacokinetics of lithium or valproate. Clin Drug Investig. 2020;40(1):55–64.
  • 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.
  • Potkin SG, Kunovac J, Silverman BL, et al. Efficacy and safety of a combination of olanzapine and samidorphan in adult patients with an acute exacerbation of schizophrenia: outcomes from the randomized, phase 3 ENLIGHTEN-1 study. J Clin Psychiatry. 2020 Mar 3;81(2):19m12769.
  • Yagoda S, Graham C, Simmons A, et al. 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. CNS Spectr. 2020 May 12; 1–10. DOI:10.1017/S1092852920001376.
  • Correll CU, Newcomer JW, Silverman B, et al. Effects of olanzapine combined with samidorphan on weight gain in schizophrenia: a 24-week phase 3 study. Am J Psychiatry. 2020;177(12):1168–1178.
  • Kahn RS, Silverman BL, DiPetrillo L, et al. A phase 3, multicenter study to assess the 1-year safety and tolerability of a combination of olanzapine and samidorphan in patients with schizophrenia: results from the ENLIGHTEN-2 long-term extension. Schizophr Res. 2021;232:45–53.
  • Leucht S, Cipriani A, Spineli L, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis [published correction appears in Lancet. 2013 Sep 14;382(9896):940]. Lancet. 2013;382(9896):951–962.
  • Huhn M, Nikolakopoulou A, Schneider-Thoma J, et al. Comparative efficacy and tolerability of 32 oral antipsychotics for the acute treatment of adults with multi-episode schizophrenia: a systematic review and network meta-analysis [published correction appears in Lancet. 2019 Sep 14;394(10202):918]. Lancet. 2019;394(10202):939–951.
  • Lieberman JA, Stroup TS, McEvoy JP, et al. Effectiveness of antipsychotic drugs in patients with chronic schizophrenia [published correction appears in N Engl J Med. 2010 Sep 9;363(11):1092-3]. N Engl J Med. 2005;353(12):1209–1223.
  • Sun L, McDonnell D, Liu J, et al. 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.
  • Tek C, Ratliff J, Reutenauer E, et al. A randomized, double-blind, placebo-controlled pilot study of naltrexone to counteract antipsychotic-associated weight gain: proof of concept. J Clin Psychopharmacol. 2014;34(5):608–612.
  • Shram MJ, Silverman B, Ehrich E, et al. Use of remifentanil in a novel clinical paradigm to characterize onset and duration of opioid blockade by samidorphan, a potent μ-receptor antagonist. J Clin Psychopharmacol. 2015;35(3):242–249.
  • Citrome L, O’Malley SS, McDonnell D, et al. Olanzapine plus samidorphan in subjects with schizophrenia and comorbid alcohol use disorder: rationale and design for a phase II, double-blind, randomized study. Innov Clin Neurosci. 2019;16(5–6):15–21.
  • Kassahun K, Mattiuz E, Nyhart EsJr, et al. Disposition and biotransformation of the antipsychotic agent olanzapine in humans. Drug Metab Dispos. 1997;25(1):81–93.
  • Ring BJ, Catlow J, Lindsay TJ, et al. Identification of the human cytochromes P450 responsible for the in vitro formation of the major oxidative metabolites of the antipsychotic agent olanzapine. J Pharmacol Exp Ther. 1996;276(2):658–666.
  • Fava GA. Financial conflicts of interest in psychiatry. World Psychiatry. 2007;6(1):19–24.

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