Investigational opioid antagonists for treating opioid-induced bowel dysfunction

References

• Center for Substance Abuse Treatment. Managing chronic pain in adults with or in recovery from substance use disorders. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2012.
   Google Scholar
• Lee AA, Hasler WL. Opioids and GI motility-friend or foe? Curr Treat Options Gastroenterol. 2016;14:478–494.
   PubMedGoogle Scholar
• Holder RM, Rhee D. Novel oral therapies for opioid-induced bowel dysfunction in patients with chronic noncancer pain. Pharmacotherapy. 2016;36:287–299.
   PubMed Web of Science ®Google Scholar
• Leppert W. Emerging therapies for patients with symptoms of opioid-induced bowel dysfunction. Drug Des Devel Ther. 2015;9:2215–2231.
   PubMed Web of Science ®Google Scholar
• Poulsen JL, Brock C, Olesen AE, et al. Evolving paradigms in the treatment of opioid-induced bowel dysfunction. Therap Adv Gastroenterol. 2015;8:360–372.
   PubMed Web of Science ®Google Scholar
• Sharma A, Jamal MM. Opioid induced bowel disease: a twenty-first century physicians’ dilemma. Considering pathophysiology and treatment strategies. Curr Gastroenterol Rep. 2013;15:334.
   PubMedGoogle Scholar
• Camilleri M. Opioid-induced constipation: challenges and therapeutic opportunities. Am J Gastroenterol. 2011;106:835–842.
   PubMed Web of Science ®Google Scholar
• Panchal SJ, Müller-Schwefe W. Opioid-induced bowel dysfunction: prevalence, pathophysiology and burden. Int Clin Pract. 2007;61(7):1181–1187.
   PubMed Web of Science ®Google Scholar
• Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001;182:11S–18S.
   PubMed Web of Science ®Google Scholar
• Lugoboni F, Mirijello A, Zamboni L, et al. High prevalence of constipation and reduced quality of life in opioid-dependent patients treated with opioid substitution treatments. Expert Opin Pharmacother. 2016;17:2135–2141.
   PubMed Web of Science ®Google Scholar
• Mozaffari S, Didari T, Nikfar S, et al. Phase II drugs under clinical investigation for the treatment of chronic constipation. Expert Opin Investig Drugs. 2014;23:1485–1497.
   PubMed Web of Science ®Google Scholar
• Valentin N, Acosta A, Camilleri M. Early investigational therapeutics for gastrointestinal motility disorders: from animal studies to phase II trials. Expert Opin Investig Drugs. 2015;24:769–779.
   PubMed Web of Science ®Google Scholar
• Moultry AMGodley CB, Wanami M. A review of peripherally acting mu-opioid receptor antagonists. 2011 Modern Medicine. Available from: http://www.modernmedicine.com/modernmedicine/Clinical+News/A-review-of-peripherally-acting-mu-opioid-receptor/ArticleStandard/Article/detail/705809
   Google Scholar
• Holzer P. Treatment of opioid-induced gut dysfunction. Expert Opin Investig Drugs. 2007;16:181–194.
   PubMed Web of Science ®Google Scholar
• Mehta N, O’Connell K, Giambrone GP, et al. Efficacy of methylnaltrexone for the treatment of opiod-induced constipation: a meta-analysis and systematic review. Postgrad Med. 2016;128:282–289.
   PubMed Web of Science ®Google Scholar
• Wang CZ, Yuan CS. Pharmacologic treatment of opioid-induced constipation. Expert Opin Investig Drugs. 2013;22:1225–1227. 17. 11. Thomas J. Opioid-induced bowel dysfunction. J Pain Symptom Manage. 2008;35:103-13.
   PubMed Web of Science ®Google Scholar
• Theravance Biopharma R & D, Inc. A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of TD-1211 in Subjects With Opioid-Induced Constipation. 2011. Available from: https://clinicaltrials.gov/ct2/show/NCT01459926?term=NCT01459926&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Theravance Biopharma R & D, Inc. A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation. 2009. Available from: https://clinicaltrials.gov/ct2/show/NCT01040637?term=NCT01040637&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Theravance Biopharma R & D, Inc. A Study of TD-1211 in Subjects With Opioid-Induced Constipation (OIC). 2011. Available from: https://clinicaltrials.gov/ct2/show/NCT01401985?term=NCT01401985&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Theravance Biopharma R & D, Inc. A Study to Assess the Safety, Tolerability and Clinical Activity of TD−1211 in Patients With Opioid-Induced Constipation. 2011. Available from: https://clinicaltrials.gov/ct2/show/NCT01333540?term=NCT01333540&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Theravance Biopharma R & D, Inc. TD-1211 Single-Dose Study in Elderly and Young Healthy Subjects. 2012. Available from: https://clinicaltrials.gov/ct2/show/NCT01655771?term=NCT01655771&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• ANESTHETIC AND ANALGESIC DRUG PRODUCTS ADVISORY COMMITTEE. AXELOPRAN (TD-1211) BRIEFING DOCUMENT. (CA): Theravance Inc; 2014.
   Google Scholar
• Morlion B, Clemens KE, Dunlop W. Quality of life and healthcare resource in patients receiving opioids for chronic pain: a review of the place of oxycodone/naloxone. Clin Drug Investig. 2015;35:1–11.
   PubMed Web of Science ®Google Scholar
• Siemens W, Gaertner J, Becker G. Advances in pharmacotherapy for opioid-induced constipation - a systematic review. Expert Opin Pharmacother. 2015;16:515–532.
   PubMed Web of Science ®Google Scholar
• Singla NK, Techner LM, Gabriel K, et al. CB-5945 0.25 mg twice daily is associated with significantly increased spontaneous bowel movement and greater proportion of responders compared with placebo in patients on chronic opioid therapy for noncancer pain. Gastroenterology. 2012;143:e26–e27. NCT01207427.
   PubMed Web of Science ®Google Scholar
• Cubist Pharmaceuticals LLC.Evaluation of the Efficacy and Safety of ADL5945 Once Daily for the Treatment of Opioid-induced Constipation in Adults Taking Opioid Therapy for Chronic Noncancer Pain. 2011. Available from: https://clinicaltrials.gov/ct2/show/NCT01275755?term=NCT01275755&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Cubist Pharmaceuticals LLC. Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation. 2013. Available from: https://clinicaltrials.gov/ct2/show/study/NCT01901328?term=NCT01901328&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Cubist Pharmaceuticals LLC. Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation. 2013. Available from: https://clinicaltrials.gov/ct2/show/study/NCT01901302?term=NCT01901302&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Cubist Pharmaceuticals LLC. Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation. 2012. Available from: https://clinicaltrials.gov/ct2/show/NCT01696643?term=NCT01696643&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Cubist Pharmaceuticals LLC. The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation. 2013. Available from: https://clinicaltrials.gov/ct2/show/NCT01901341?term=NCT01901341&rank=1. (Last accessed 2017 Apr).
   Google Scholar
• Anissian L, Schwartz HW, Vincent K, et al. Subcutaneous methylnaltrexone for treatment of acute opioid-induced constipation: phase 2 study in rehabilitation after orthopedic surgery. J Hosp Med. 2012;7:67–72.
   PubMed Web of Science ®Google Scholar
• Corsetti M, Tack J. Naloxegol, a new drug for the treatment of opioid-induced constipation. Expert Opin Pharmacother. 2015;16:399–406.
   PubMed Web of Science ®Google Scholar
• Webster L, Chey WD, 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;40:771–779.
   PubMed Web of Science ®Google Scholar
• Garnock-Jones KP. Naloxegol: A review of its use in patients with opioid-induced constipation. Drugs. 2015 Mar;75(4):419–425.
   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;154:1542–1550.
   PubMed Web of Science ®Google Scholar
• Jones R, Prommer E, Backstedt D. Naloxegol: a novel therapy in the management of opioid-induced constipation. Am J Hosp Palliat Care. 2016;33:875–880.
   PubMed Web of Science ®Google Scholar
• Cuomo A, Russo G, Esposito G, et al. Efficacy and gastrointestinal tolerability of oral oxycodone/naloxone combination for chronic pain in outpatients with cancer: an observational study. Am J Hosp Palliat Care. 2014;31:867–876.
   PubMed Web of Science ®Google Scholar
• Mehta V, Alaward S, Kuravinakop S, et al. Effect of a fixed-dose opioid agonist/antagonist on constipation in patients on long-term opioids for non-malignant pain unable to tolerate laxatives. Pain Physician. 2014;17:415–424.
   PubMed Web of Science ®Google Scholar
• Ahmedzai SH, Leppert W, Janecki M, et al. Long-term safety and efficacy of oxycodone/naloxone prolonged-release tablets in patients with moderate-to-severe chronic cancer pain. Support Care Cancer. 2015;23:823–830.
   PubMed Web of Science ®Google Scholar
• Davis M, Goforth HW, Gamier P. Oxycodone combined with opioid receptor antagonists: efficacy and safety. Expert Opin Drug Saf. 2013;12:389–402.
   PubMed Web of Science ®Google Scholar
• Webster L, Nagata T, Yamada T, et al. (479) A phase 2a, randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety and efficacy of naldemedine in patients with chronic non-cancer pain and opioid-induced bowel dysfunction. J Pain. 2016;17:S94.
   Web of Science ®Google Scholar
• Shionogi. A Study of S-297995 for the Treatment of Opioid-Induced Constipation in Subjects With Non-Malignant Chronic Pain Receiving Opioid Therapy. 2011. Available from: https://clinicaltrials.gov/ct2/show/NCT01443403?term=A+Study+of+S. (Last accessed 2017 Apr).
   Google Scholar
• Hesselbarth S, Hermanns K, Oepen P. Prolonged-release oxycodone/naloxone in opioid-naïve patients - subgroup analysis of a prospective observational study. Expert Opin Pharmacother. 2015;16:457–464.
   PubMed Web of Science ®Google Scholar
• Leppert W. Oxycodone/naloxone in the management of patients with pain and opioid-induced bowel dysfunction. Curr Drug Targets. 2014;15:124–135.
   PubMed Web of Science ®Google Scholar
• Rodriguez RW. Off-label uses of alvimopan and methylnaltrexone. Am J Health Syst Pharm. 2014;71:1450–1455.
   PubMed Web of Science ®Google Scholar
• Akbarali HI, Inkisar A, Dewey WL. Site and mechanism of morphine tolerance in the gastrointestinal tract. Neurogastroenterol Motil. 2014;26:1361–1367.
   PubMed Web of Science ®Google Scholar
• Altarifi AA, David B, Muchhala KH, et al. Effects of acute and repeated treatment with the biased mu opioid receptor agonist TRV130 (oliceridine) on measures of antinociception, gastrointestinal function, and abuse liability in rodents. J Psychopharmacol. 2017;31:730–739.
   PubMed Web of Science ®Google Scholar
• Available from: https://pubchem.ncbi.nlm.nih.gov
   Google Scholar