Naloxegol for the treatment of opioid-induced constipation

References

• Manchikanti L, Helm S 2nd, Fellows B, et al. Opioid epidemic in the United States. Pain Physician 2012:15(3 Suppl):ES9-38
   Google Scholar
• Brock C, Olesen SS, Olesen AE, et al. Opioid-induced bowel dysfunction: pathophysiology and management. Drugs 2012;72(14):1847-65
   PubMed Web of Science ®Google Scholar
• Holzer P. Opioid receptors in the gastrointestinal tract. Regul Pept 2009;155(1-3):11-17
   PubMed Web of Science ®Google Scholar
• Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain 2004;112(3):372-80
   PubMed Web of Science ®Google Scholar
• Sykes NP. The relationship between opioid use and laxative use in terminally ill cancer patients. Palliat Med 1998;12(5):375-82
   PubMed Web of Science ®Google Scholar
• Lapane KL, Quilliam BJ, Benson C, et al. Gastrointestinal events after opioid treatment in nonmalignant pain: correlates of occurrence and impact on health-related quality of life. J Opioid Manag 2013;9(3):205-16
   Google Scholar
• Bell T, Annunziata K, Leslie JB. Opioid-induced constipation negatively impacts pain management, productivity, and health-related quality of life: findings from the National Health and Wellness Survey. J Opioid Manag 2009;5(3):137-44
   PubMedGoogle Scholar
• Tack J, Müller-Lissner S. Treatment of chronic constipation: current pharmacologic approaches and future directions. Clin Gastroenterol Hepatol 2009;7(5):502-8
   PubMed Web of Science ®Google Scholar
• Caraceni A, Hanks G, Kaasa S, European Palliative Care Research Collaborative (EPCRC); European Association for Palliative Care (EAPC). Use of opioid analgesics in the treatment of cancer pain: evidence-based recommendations from the EAPC. Lancet Oncol 2012;13(2):e58-68
   PubMed Web of Science ®Google Scholar
• Candy B, Jones L, Goodman ML, et al. Laxatives or methylnaltrexone for the management of constipation in palliative care patients. Cochrane Database Syst Rev 2011(1):CD003448
   PubMed Web of Science ®Google Scholar
• Twycross RG, McNamara P, Schuijt C, et al. Sodium picosulfate in opioid-induced constipation: results of an open-label, prospective, dose-ranging study. Palliat Med 2006;20(4):419-23
   PubMed Web of Science ®Google Scholar
• Cryer BL, Katz S, Vallejo R, et al. A phase 3, randomized, double-blind, placebo-controlled clinical trial of lubiprostone for the treatment of opioid-induced bowel dysfunction in patients with chronic, non-cancer pain. Gastroenterology 2010;138(suppl 1):S129
   Google Scholar
• 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):2912-21
   PubMed Web of Science ®Google Scholar
• Liu M, Wittbrodt E. Low-dose oral naloxone reverses opioid-induced constipation and analgesia. J Pain Symptom Manage 2002;23:48-53
   PubMed Web of Science ®Google Scholar
• Löwenstein O, Leyendecker P, Lux EA, et al. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials. BMC Clin Pharmacol 2010;10:12
   PubMedGoogle Scholar
• Meissner W, Leyendecker P, Mueller-Lissner S, et al. A randomised controlled trial with prolonged-release oral oxycodone and naloxone to prevent and reverse opioid-induced constipation. Eur J Pain 2009;13(1):56-64
   PubMed Web of Science ®Google Scholar
• Burness CB, Keating GM. Oxycodone/Naloxone prolonged-release: a review of its use in the management of chronic pain while counteracting opioid-induced constipation. Drugs 2014;74(3):353-75
   PubMed Web of Science ®Google Scholar
• Mercadante S, Ferrera P, Adile C. High doses of oxycodone-naloxone combination may provide poor analgesia. Support Care Cancer 2011;19(9):1471-2
   PubMed Web of Science ®Google Scholar
• Mackey AC, Green L, Greene P, Avigan M. Methylnaltrexone and gastrointestinal perforation. J Pain Symptom Manage 2010;40(1):e1-3
   PubMedGoogle Scholar
• Ford AC, Brenner DM, Schoenfeld PS. Efficacy of pharmacological therapies for the treatment of opioid-induced constipation: systematic review and meta-analysis. Am J Gastroenterol 2013;108(10):1566-74
   PubMed Web of Science ®Google Scholar
• Vaughan-Shaw PG, Fecher IC, Harris S, Knight JS. A meta-analysis of the effectiveness of the opioid receptor antagonist alvimopan in reducing hospital length of stay and time to GI recovery in patients enrolled in a standardized accelerated recovery program after abdominal surgery. Dis Colon Rectum 2012;55(5):611-20
   PubMed Web of Science ®Google Scholar
• GlaxoSmithKline and Adolor Corporation. GSK and Adolor announce preliminary results from phase 3 safety study of alvimopan (Entereg/Entrareg). Available from: www.gsk.com/media/press-releases/2007/gsk-and-adolor-announce-preliminary-results-from-phase-3-safety-study-of-alvimopan-enteregentrareg.html [Last accessed 30 March 2014]
   Google Scholar
• Oral NKTR-118 (oral PEG-naloxol), a PEGylated derivative of naloxone; demonstration of selective peripheral opioid antagonism after oral administration in preclinical models. Poster presented at the American Academy of Pain Management Meeting in Las Vegas, Nevada – 28 September 2007. Available from: www.nektar.com/pdf/pipeline/NKTR-118/NKTR-118_aapm_2007_preclinical_data_poster_28.pdf [Last accessed on 30 March 2014]
   Google Scholar
• NKTR-118, An oral peripheral opioid antagonist, has low potential for drug-drug interactions. Poster presented at the ACCP 38th Annual Meeting – 13 September 2008. Available from: www.nektar.com/pdf/pipeline/NKTR-118/ACCP38thAnnualMeetingPoster141.pdf [Last accessed on 30 March 2014]
   Google Scholar
• Evaluation of PEG-naloxol NKTR-118 as an oral peripheral opioid antagonist in healthy male subjects: a double-blind, placebo-controlled, dose escalation crossover study. Poster presented at the American College of Clinical Pharmacology 36th Annual Meeting in San Francisco, CA – 10 September 2007. Available form: www.nektar.com/pdf/pipeline/NKTR-118/NKTR-118_aacp2007_single-dose_phase_1_trial.pdf [Last accessed on 30 March 2014]
   Google Scholar
• “Comparative bioavailability of NKTR-118 tablets and solution: a case of bioequivalence between dosage forms for a rapidly absorbed drug”. Poster presented at the ACCP 38th Annual Meeting – 13 September 2008. Available form: www.nektar.com/pdf/pipeline/NKTR-118/ACCP38thAnnualMeetingPoster140.pdf [Last accessed on 30 March 2014]
   Google Scholar
• Gottfridsson C, Carlson G, Lappalainen J, Sostek M. 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):1876-83
   PubMed Web of Science ®Google Scholar
• 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;154:1542-50
   PubMed Web of Science ®Google Scholar
• Chey WD, Webster L, Sostek M, Tack J. Efficacy and safety of naloxegol in patients with opioid-induced constipation: results from 2 prospective, randomized, controlled trials. Gastroenterology 2013;144(5Supp 1):S159-60; abstract
   Google Scholar
• Tack J, Chey WD, Webster L, et al. Efficacy of naloxegol in a subpopulation of patients with opioid-induced constipation and an inadequate baseline response to laxatives: results from 2 prospective, randomized, controlled trials. United European Gastroenterol J 2013;1(suppl 1):A49; abstract
   Google Scholar
• AstraZeneca announces top-line phase III results from naloxegol pivotal trials in patients with opioid-induced constipation. Available from: www.astrazeneca.com/Media/Press-releases/Article/20121211–astrazeneca-announces-topline [Last accessed 30 March 2014]
   Google Scholar
• Von Roenn JH, Tack J, Barker PN, et al. Challenges in patient recruitment during KODIAC-06, a randomized, placebo-controlled, double-blind, multicenter, phase 3 trial of naloxegol in patients with neoplasia and opioid-induced constipation. Presented at the International Symposium on Supportive Care in Cancer, Berlin; 27-29 June 2013. Available from: http://mascc.meetingxpert.net/MASCC_466/poster_67568/program.aspx. [Last accessed on 30 March 2014]
   Google Scholar