References
- Information sheet on opioid overdose. World Health Organization: WHO, Management of substance abuse, Aug 2018 [cited 2019 Oct]. Available from: https://www.who.int/substance_abuse/information-sheet/en/.
- Brock C, Olesen SS, Olesen AE, et al. Opioid-induced bowel dysfunction. Drugs. 2012;72(14):1847–1865.
- Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001;182(5):S11–S18.
- Thorpe DM. Management of opioid-induced constipation. Curr Pain Headache Rep. 2001;5(3):237–240.
- Gyawali B, Hayashi N, Tsukuura H, et al. Opioid-induced constipation. Scand J Gastroenterol. 2015;50(11):1331–1338.
- Nelson AD, Camilleri M. Opioid-induced constipation: advances and clinical guidance. Ther Adv Chronic Dis. 2016;7(2):121–134.
- Kalso E, Edwards JE, Moore RA, et al. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain. 2004;112(3):372–380.
- Initiatives, opioid induced constipation. AAPM foundation. Chicago: American Academy of Pain Medicine Foundation. 2019. Available from: http://aapmfoundation.org/initiatives
- Drewes AM, Munkholm P, Simrén M, et al. Definition, diagnosis and treatment strategies for opioid-induced bowel dysfunction–recommendations of the nordic working group. Scand J Pain. 2016;11(1):111–122.
- Farmer AD, Holt CB, Downes TJ, et al. Pathophysiology, diagnosis, and management of opioid-induced constipation. Lancet Gastroenterol Hepatol. 2018;3(3):203–212.
- Dorn S, Lembo A, Cremonini F. Opioid-induced bowel dysfunction: epidemiology, pathophysiology, diagnosis, and initial therapeutic approach. Am J Gastroenterol Suppl. 2014;2(1):31.
- Argoff CE, Brennan MJ, Camilleri M, et al. Consensus recommendations on initiating prescription therapies for opioid-induced constipation. Pain Med. 2015;16(12):2324–2337.
- Olesen AE, Drewes AM. Validated tools for evaluating opioid-induced bowel dysfunction. Adv Ther. 2011;28(4):279–294.
- Mozaffari S, Nikfar S, Abdollahi M. Methylnaltrexone bromide for the treatment of opioid-induced constipation. Expert Opin Pharmacother. 2018;19(10):1127–1135.
- Draft Guidance on Naloxegol Oxalate. FDA. Washington, DC: Food and Drug Administration (FDA, or the Agency); 2015. [cited Oct 2019]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/psg/Naloxegol%20oxalate_oral%20tablet_NDA%20204760_RV11-17.pdf
- Chey WD, Webster L, Sostek M, et al. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014;370(25):2387–2396.
- Neumann TA, van Patischen H, Marcantonio A, et al. Evaluation of single oral doses of NKTR118 (PEG-Naloxol) as a peripheral opioid antagonist (POA): a double-blind placebo-controlled study in healthy male subjects. J Clin Pharmacol. 2007;32:1210.
- Webster L, Chey W, Tack J, et al. Randomised clinical trial: the long‐term safety and tolerability of naloxegol in patients with pain and opioid‐induced constipation. Aliment Pharmacol Ther. 2014;40(7):771–779.
- Vickery RG, Li Y-P, Schwertschlag U, et al. 899 Td-1211 phase 2B study demonstrates increased bowel movement frequency and constipation-related symptom improvement in patients with opioid induced constipation (OIC). Gastroenterology. 2013;144(5):S–159.
- Hale M, Wild J, Reddy J, et al. Naldemedine versus placebo for opioid-induced constipation (COMPOSE-1 and COMPOSE-2): two multicentre, phase 3, double-blind, randomised, parallel-group trials. Lancet Gastroenterol Hepatol. 2017;2(8):555–564.
- Application Number: 204760Orig1s000. FDA Public Health Advisory. Washington, DC: FDA/Center for Drug Evaluation and Research; 2014. Available from: http://accessdata.fda.gov/drugsatfda_docs/nda/2014/204760Orig1s000Approv.pdf
- Smith K, Hopp M, Mundin G, et al. Low absolute bioavailability of oral naloxone in healthy subjects. Int J Clin Pharmacol Ther. 2012;50(5):360–367.
- Sternini C, Patierno S, Selmer IS, et al. The opioid system in the gastrointestinal tract. J Neurogastroenterol Motil. 2004;16:3–16.
- Wood JD, Galligan J. Function of opioids in the enteric nervous system. J Neurogastroenterol Motil. 2004;16:17–28.
- Gonenne J, Camilleri M, Ferber I, et al. Effect of alvimopan and codeine on gastrointestinal transit: a randomized controlled study. Clin Gastroenterol Hepatol. 2005;3(8):784–791.
- Kraichely R, Arora A, Murray JA. Opiate‐induced oesophageal dysmotility. Aliment Pharmacol Ther. 2010;31(5):601–606.
- Mozaffari S, Nikfar S, Abdollahi M. Investigational opioid antagonists for treating opioid-induced bowel dysfunction. Expert Opin Investig Drugs. 2018;27(3):235–242.
- Olesen AE, Grønlund D, Mark EB, et al. Effects of naloxegol on gastrointestinal transit and colonic fecal volume in healthy participants receiving oxycodone. J Neurogastroenterol Motil. 2019;25(4):602.
- Mark EB, Poulsen JL, Haase AM, et al. Ambulatory assessment of colonic motility using the electromagnetic capsule tracking system. Neurogastroenterol Motil. 2019;31(2):13451.
- Movantik U.S. Prescribing Information. Cambridge, United Kingdom; 2015. [Updated Jan 2015; cited Oct 2019]. Available from: http://accessdata.fda.gov/drugsatfda_docs/label/2019/204760s008lbl.pdf
- Akbarali H, Inkisar A, Dewey W. Site and mechanism of morphine tolerance in the gastrointestinal tract. Neurogastroenterol Motil. 2014;26(10):1361–1367.
- Webster L, Dhar S, Eldon M, et al. A phase 2, double-blind, randomized, placebo-controlled, dose-escalation study to evaluate the efficacy, safety, and tolerability of naloxegol in patients with opioid-induced constipation. Pain. 2013;154(9):1542–1550.
- Naloxegol Briefing Document for the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC). Astrazeneca Pharmaceuticals. Cambridge, UK; 2014. [cited Oct 2019]. Available from: https://www.fda.gov/media/121233/download
- Bui K, She F, Sostek M. The effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014;54(12):1368–1374.
- Garnock-Jones KP. Naloxegol: a review of its use in patients with opioid-induced constipation. Drugs. 2015;75(4):419–425.
- Bui K, She F, Sostek M. The effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegol. J Clin Pharmacol. 2014;54(12):1375–1382.
- Eldon MA, Kugler AR, Medve RA, et al. Safety, tolerability, pharmacokinetics, and pharmacodynamic effects of naloxegol at peripheral and central nervous system receptors in healthy male subjects: a single ascending‐dose study. Clin Pharmacol Drug Dev. 2015;4(6):434–441.
- Movantiktm (naloxegol tablets): US prescribing information. Cambridge, United Kingdom: Astrazeneca; 2014. [cited Oct 2019]. Available from: http://www.astrazeneca-us.com/cgibin/az_pi.cgi?Product=movantik&country=us&popup=no
- Moventig_ (naloxegol oxalate tablets): EU summary of product characterisitics. London: European Medicines Agency; 2014 [cited Sep 2019]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/002810/WC500179075.pdf
- Astrazeneca. Open label, healthy volunteers, bioequivalence study with naloxegol. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT01623609 NLM Identifier: NCT01623609.
- Camilleri M. Effect of naloxegol on gastric, small bowel, and colonic transit in healthy subjects. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT02737059?Term=naloxegol&phase=0&draw=2 NLM Identifier: NCT02737059
- Bui K, Birmingham B, Diva U, et al. Randomized bioavailability study of alternative methods of oral administration of naloxegol in healthy subjects. Clin Pharmacol Drug Dev. 2017;6(4):420–427.
- Ma J. Naloxegol in cancer opioid-induced constipation. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT02745353?Term=naloxegol&phase=01&draw=2&rank=1 NLM Identifier: NCT02745353
- Temple University. Movantik for opioid-related esophageal disorders. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT02998606?Term=naloxegol&phase=1&draw=2&rank=2 NLM Identifier: NCT02998606
- Temple University. Naloxegol for opioid-related gastroparesis. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT03036891?Term=naloxegol&phase=1&draw=2&rank=3 NLM Identifier NCT03036891
- Astrazeneca. A phase 2, double-blind, multiple-dose escalation study to evaluate NKTR-118 (Oral PEG-Naloxol) in patients with opioid-induced constipation (OIC). In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT00600119?Term=naloxegol&phase=1&draw=2&rank=5 NLM Identifier: NCT00600119
- Astrazeneca. Assessment of efficacy and safety in patients with non-cancer-related pain and opioid-induced constipation. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT01323790 NLM Identifier: NCT01323790
- Webster L, Tummala R, Diva U, et al. A 12-week extension study to assess the safety and tolerability of naloxegol in patients with noncancer pain and opioid-induced constipation. J Opioid Manag. 2016;12(6):405–419.
- Massachusetts General Hospital. The effect of naloxegol on refractory constipation in the intensive care unit (narc-ICU). In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT02705378?Term=naloxegol&phase=2&draw=2&rank=1. NLM Identifier: NCT02705378
- Brenner DM, Hu Y, Datto C, et al. A randomized, multicenter, prospective, crossover, open-label study of factors associated with patient preferences for naloxegol or PEG 3350 for opioid-induced constipation. Am J Gastroenterol. 2019;114(6):954–963.
- Massachusetts General Hospital. Naloxegol for the prevention of constipation in postoperative spinal surgery patients. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT02946580?Term=naloxegol&phase=3&draw=2&rank=4. NLM Identifier: NCT02946580
- Tufts Medical Center. Naloxegol to prevent lower gastrointestinal paralysis in critically ill adults administered opioids. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT02977286 NLM Identifier: NCT02977286.
- University of Missouri-Columbia methylnaltrexone vs naloxegol in the treatment of opioid-induced constipation. In: clinicaltrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US); 2000. [cited 2019 Sep]. Available from: https://clinicaltrials.gov/ct2/show/NCT03523520?Term=naloxegol&phase=3&draw=2&rank=6 NLM Identifier: NCT03523520
- Yoon SC, Bruner HC. Naloxegol in opioid-induced constipation: a new paradigm in the treatment of a common problem. Patient Prefer Adherence. 2017;11:1265.
- Tack J, Lappalainen J, Diva U, et al. Efficacy and safety of naloxegol in patients with opioid-induced constipation and laxative-inadequate response. United European Gastroenterol J. 2015;3(5):471–480.
- Bruner HC, Atayee RS, Edmonds KP, et al. Clinical utility of naloxegol in the treatment of opioid-induced constipation. J Pain Res. 2015;8:289.
- Viscusi ER. Clinical overview and considerations for the management of opioid-induced constipation in patients with chronic noncancer pain. Clin J Pain. 2019;35(2):174.
- Gottfridsson C, Carlson G, Lappalainen J, et al. Evaluation of the effect of naloxegol on cardiac repolarization: a randomized, placebo-and positive-controlled crossover thorough QT/qtc study in healthy volunteers. Clin Ther. 2013;35(12):1876–1883.
- White WB, Kowey P, Diva U, et al. cardiovascular safety of the selective μ-opioid receptor antagonist naloxegol: a novel therapy for opioid-induced constipation. J Cardiovasc Pharmacol Ther. 2018;23(4):309–317.
- Leppert W, Woron J. The role of naloxegol in the management of opioid-induced bowel dysfunction. Therap Adv Gastroenterol. 2016;9(5):736–746.
- Bharucha AE, Pemberton JH, Locke GR. American Gastroenterological Association technical review on constipation. Gastroenterology. 2013;144(1):218–238.
- Eswaran S, Muir J, Chey WD. Fiber and functional gastrointestinal disorders. Am J Gastroenterol. 2013;108(5):718.
- Skollerud LM, Fredheim OM, Svendsen K, et al. Laxative prescriptions to cancer outpatients receiving opioids: a study from the Norwegian prescription database. Supportive Care Cancer. 2013;21(1):67–73.
- Tassinari D, Sartori S, Tamburini E, et al. Adverse effects of transdermal opiates treating moderate-severe cancer pain in comparison to long-acting morphine: a meta-analysis and systematic review of the literature. J Palliat Med. 2008;11(3):492–501.
- Pottegård A, Knudsen TB, van Heesch K, et al. Information on risk of constipation for Danish users of opioids, and their laxative use. Int J Clin Pharm. 2014;36(2):291–294.
- Mozaffari S, Nikfar S, Abdollahi M. Phase II drugs under clinical investigation for the treatment of chronic constipation. Expert Opin Investig Drugs. 2014;23(11):1485–1497.
- Koopmans-Klein G, Wagemans MF, Wartenberg HC, et al. The efficacy of standard laxative use for the prevention and treatment of opioid induced constipation during oxycodone use: a small Dutch observational pilot study. Expert Rev Gastroenterol Hepatol. 2016;10(4):547–553.
- Daniali M, Nikfar S, Abdollahi M. An overview of the efficacy and safety of prucalopride for the treatment of chronic idiopathic constipation. Expert Opin Pharmacother. 2019;20(17):2073–2080.
- Sloots CE, Rykx A, Cools M, et al. Efficacy and safety of prucalopride in patients with chronic noncancer pain suffering from opioid-induced constipation. Dig Dis Sci. 2010;55(10):2912–2921.
- De Schepper H, Cremonini F, Park MI, et al. Opioids and the gut: pharmacology and current clinical experience. Neurogastroenterol Motil. 2004;16(4):383–394.