Clinical potential of naloxegol in the management of opioid-induced bowel dysfunction

References

• TrescotAMGlaserSEHansenHBenyaminRPatelSManchikantiLEffectiveness of opioids in the treatment of chronic non-cancer painPain Physician200811Suppl 2S181S20018443639
   PubMed Web of Science ®Google Scholar
• JiRRZhangQLawPYLowHHEldeRHökfeltTExpression of mu-, delta-, and kappa-opioid receptor-like immunoreactivities in rat dorsal root ganglia after carrageenan-induced inflammationJ Neurosci19951512815681668613750
   PubMed Web of Science ®Google Scholar
• LaduronPMAxonal transport of opiate receptors in capsaicin- sensitive neuronesBrain Res198429411571606199089
   PubMed Web of Science ®Google Scholar
• BrockCOlesenSSOlesenAEFrøkjaerJBAndresenTDrewesAMOpioid-induced bowel dysfunction: pathophysiology and managementDrugs201272141847186522950533
   PubMed Web of Science ®Google Scholar
• PappagalloMIncidence, prevalence, and management of opioid bowel dysfunctionAm J Surg2001182Suppl 5A11S18S11755892
   PubMed Web of Science ®Google Scholar
• LooströmHAkermanSEricsonDTobinGGötrickBTramadol-induced oral dryness and pilocarpine treatment: effects on total protein and IgAArch Oral Biol201156439540021112044
   PubMed Web of Science ®Google Scholar
• KurzASesslerDIOpioid-induced bowel dysfunction: pathophysiology and potential new therapiesDrugs200363764967112656645
   PubMed Web of Science ®Google Scholar
• ThorpeDMManagement of opioid-induced constipationCurr Pain Headache Rep20015323724011309211
   PubMedGoogle Scholar
• TamayoACDiaz-ZuluagaPAManagement of opioid-induced bowel dysfunction in cancer patientsSupport Care Cancer200412961361815221581
   PubMed Web of Science ®Google Scholar
• AfilaloMMorlionBEfficacy of tapentadol ER for managing moderate to severe chronic painPain Physician2013161274023340531
   PubMed Web of Science ®Google Scholar
• NiestersMProtoPLAartsLSartonEYDrewesAMDahanATapentadol potentiates descending pain inhibition in chronic pain patients with diabetic polyneuropathyBr J Anaesth2014113114815624713310
   PubMed Web of Science ®Google Scholar
• WebsterLDharSEldonMMasuokaLLappalainenJSostekMA phase 2, double-blind, randomized, placebo-controlled, dose-escalation study to evaluate the efficacy, safety, and tolerability of naloxegol in patients with opioid-induced constipationPain201315491542155023726675
   PubMed Web of Science ®Google Scholar
• TutejaAKBiskupiakJStoddardGJLipmanAGOpioid-induced bowel disorders and narcotic bowel syndrome in patients with chronic non-cancer painNeurogastroenterol Motil201022442443020100280
   PubMed Web of Science ®Google Scholar
• ChoungRSLockeGR3rdZinsmeisterARSchleckCDTalleyNJOpioid bowel dysfunction and narcotic bowel syndrome: a population-based studyAm J Gastroenterol200910451199120419367263
   PubMed Web of Science ®Google Scholar
• GlarePWalshDSheehanDThe adverse effects of morphine: a prospective survey of common symptoms during repeated dosing for chronic cancer painAm J Hosp Palliat Care200623322923517060284
   PubMedGoogle Scholar
• AllanLHaysHJensenNHRandomised crossover trial of transdermal fentanyl and sustained release oral morphine for treating chronic non-cancer painBMJ200132272951154115811348910
   PubMed Web of Science ®Google Scholar
• BellTJPanchalSJMiaskowskiCBolgeSCMilanovaTWilliamsonRThe prevalence, severity, and impact of opioid-induced bowel dysfunction: results of a US and European Patient Survey (PROBE 1)Pain Med2009101354218721170
   PubMed Web of Science ®Google Scholar
• CookSFLanzaLZhouXGastrointestinal side effects in chronic opioid users: results from a population-based surveyAliment Pharmacol Ther200827121224123218363893
   PubMed Web of Science ®Google Scholar
• KalsoEEdwardsJEMooreRAMcQuayHJOpioids in chronic non-cancer pain: systematic review of efficacy and safetyPain2004112337238015561393
   PubMed Web of Science ®Google Scholar
• MooreRAMcQuayHJPrevalence of opioid adverse events in chronic non-malignant pain: systematic review of randomised trials of oral opioidsArthritis Res Ther200575R1046R105116207320
   PubMed Web of Science ®Google Scholar
• SanchezMIBercikPEpidemiology and burden of chronic constipationCan J Gastroenterol201125Suppl B11B15B
   PubMedGoogle Scholar
• WirzSNadstawekJElsenCJunkerUWartenbergHCLaxative management in ambulatory cancer patients on opioid therapy: a prospective, open-label investigation of polyethylene glycol, sodium picosulphate and lactuloseEur J Cancer Care (Engl)201221113114021880080
   PubMed Web of Science ®Google Scholar
• HigginsPDJohansonJFEpidemiology of constipation in North America: a systematic reviewAm J Gastroenterol200499475075915089911
   PubMed Web of Science ®Google Scholar
• BrilSShohamYMarcusJThe “mystery” of opioid-induced diarrheaPain Res Manag201116319719921766071
   PubMed Web of Science ®Google Scholar
• JohansonJFKralsteinJChronic constipation: a survey of the patient perspectiveAliment Pharmacol Ther200725559960817305761
   PubMed Web of Science ®Google Scholar
• FurnessJCostaMThe Enteric Nervous SystemEdinburghChurchill Livingstone1987
   Google Scholar
• AzizQThompsonDGBrain-gut axis in health and diseaseGastroenterology199811435595789496948
   PubMed Web of Science ®Google Scholar
• WoodJDEnteric nervous system: sensory physiology, diarrhea and constipationCurr Opin Gastroenterol201026210210819926984
   PubMed Web of Science ®Google Scholar
• FurnessJBKunzeWABertrandPPClercNBornsteinJCIntrinsic primary afferent neurons of the intestineProg Neurobiol19985411189460790
   PubMed Web of Science ®Google Scholar
• HolzerPTreatment of opioid-induced gut dysfunctionExpert Opin Investig Drugs2007162181194
   PubMed Web of Science ®Google Scholar
• SterniniCPatiernoSSelmerISKirchgessnerAThe opioid system in the gastrointestinal tractNeurogastroenterol Motil200416Suppl 231615357847
   PubMed Web of Science ®Google Scholar
• HuizingaJDLammersWJGut peristalsis is governed by a multitude of cooperating mechanismsAm J Physiol Gastrointest Liver Physiol20092961G1G818988693
   PubMed Web of Science ®Google Scholar
• FioravantiBVanderahTWThe ORL-1 receptor system: are there opportunities for antagonists in pain therapy?Curr Top Med Chem20088161442145118991730
   PubMed Web of Science ®Google Scholar
• Greenwood-Van MeerveldBGardnerCJLittlePJHicksGADehaven-HudkinsDLPreclinical studies of opioids and opioid antagonists on gastrointestinal functionNeurogastroenterol Motil200416Suppl 2465315357851
   PubMed Web of Science ®Google Scholar
• JordanBDeviLAMolecular mechanisms of opioid receptor signal transductionBr J Anaesth199881112199771268
   PubMed Web of Science ®Google Scholar
• SharmaSKNirenbergMKleeWAMorphine receptors as regulators of adenylate cyclase activityProc Natl Acad Sci U S A19757225905941054841
   PubMed Web of Science ®Google Scholar
• WoodJDGalliganJJFunction of opioids in the enteric nervous systemNeurogastroenterol Motil200416Suppl 2172815357848
   PubMed Web of Science ®Google Scholar
• SarnaSKOttersonMFSmall intestinal amyogenesia and dysmyogenesia induced by morphine and loperamideAm J Physiol19902582 Pt 1G282G2891968317
   PubMed Web of Science ®Google Scholar
• ThomasJOpioid-induced bowel dysfunctionJ Pain Symptom Manage200835110311317981003
   PubMed Web of Science ®Google Scholar
• RaoSSConstipation: evaluation and treatment of colonic and anorectal motility disordersGastroenterol Clin North Am200736368771117950444
   PubMed Web of Science ®Google Scholar
• ParkmanHPAssessment of gastric emptying and small-bowel motility: scintigraphy, breath tests, manometry, and SmartPillGastrointest Endosc Clin N Am2009191495519232280
   PubMedGoogle Scholar
• MaqboolSParkmanHPFriedenbergFKWireless capsule motility: comparison of the SmartPill GI monitoring system with scintigraphy for measuring whole gut transitDig Dis Sci200954102167217419655250
   PubMed Web of Science ®Google Scholar
• ZhangWQYanGZYeDDChenCWSimultaneous assessment of the intraluminal pressure and transit time of the colon using a telemetry techniquePhysiol Meas200728214114817237586
   PubMed Web of Science ®Google Scholar
• StathopoulosESchlageterVMeyratBRibaupierreYKuceraPMagnetic pill tracking: a novel non-invasive tool for investigation of human digestive motilityNeurogastroenterol Motil200517114815415670274
   PubMed Web of Science ®Google Scholar
• HirozPSchlageterVGivelJCKuceraPColonic movements in healthy subjects as monitored by a Magnet Tracking SystemNeurogastroenterol Motil2009218838e5719400925
   PubMed Web of Science ®Google Scholar
• MurekMKopicSGeibelJEvidence for intestinal chloride secretionExp Physiol201095447147820233891
   PubMed Web of Science ®Google Scholar
• BarrettKEKeelySJChloride secretion by the intestinal epithelium: molecular basis and regulatory aspectsAnnu Rev Physiol20006253557210845102
   PubMed Web of Science ®Google Scholar
• KunzelmannKMallMElectrolyte transport in the mammalian colon: mechanisms and implications for diseasePhysiol Rev200282124528911773614
   PubMed Web of Science ®Google Scholar
• LiYXiangYYLuWYLiuCLiJA novel role of intestine epithelial GABAergic signaling in regulating intestinal fluid secretionAm J Physiol Gastrointest Liver Physiol20123034G453G46022700823
   PubMed Web of Science ®Google Scholar
• ThomasPDForbesAGreenJGuidelines for the investigation of chronic diarrhoea, 2nd edGut200352Suppl 5v1v1512801941
   PubMedGoogle Scholar
• EhererAJFordtranJSFecal osmotic gap and pH in experimental diarrhea of various causesGastroenterology199210325455511634072
   PubMed Web of Science ®Google Scholar
• van de KerkhofEGUngellALSjöbergAKInnovative methods to study human intestinal drug metabolism in vitro: precision-cut slices compared with ussing chamber preparationsDrug Metab Dispos200634111893190216914511
   PubMed Web of Science ®Google Scholar
• LarsenRMertz-NielsenAHansenMBPoulsenSSBindslevNNovel modified Ussing chamber for the study of absorption and secretion in human endoscopic biopsiesActa Physiol Scand2001173221322211683679
   PubMedGoogle Scholar
• OsbakPSBindslevNPoulsenSSKaltoftNTilottaMCHansenMBColonic epithelial ion transport is not affected in patients with diverticulosisBMC Gastroenterol200773717888183
   PubMed Web of Science ®Google Scholar
• SunXWangXWangGDLubiprostone reverses the inhibitory action of morphine on mucosal secretion in human small intestineDig Dis Sci201156233033821181441
   PubMed Web of Science ®Google Scholar
• KaltoftNTilottaMCWitteABProstaglandin E2-induced colonic secretion in patients with and without colorectal neoplasiaBMC Gastroenterol201010920100359
   PubMed Web of Science ®Google Scholar
• ToouliJSphincter of Oddi: Function, dysfunction, and its managementJ Gastroenterol Hepatol200924Suppl 3S57S6219799700
   PubMed Web of Science ®Google Scholar
• PenaginiRBartesaghiBZanniniPNegriGBianchiPALower oesophageal sphincter hypersensitivity to opioid receptor stimulation in patients with idiopathic achalasiaGut199334116208381758
   PubMed Web of Science ®Google Scholar
• KraichelyREAroraASMurrayJAOpiate-induced oesophageal dysmotilityAliment Pharmacol Ther201031560160620003176
   PubMed Web of Science ®Google Scholar
• ThorénTCarlssonESandmarkSWattwilMEffects of thoracic epidural analgesia with morphine or bupivacaine on lower oesophageal motility – an experimental study in manActa Anaesthesiol Scand19883253913943414347
   PubMed Web of Science ®Google Scholar
• HelmJFVenuRPGeenenJEEffects of morphine on the human sphincter of OddiGut19882910140214073197985
   PubMed Web of Science ®Google Scholar
• ThompsonDRNarcotic analgesic effects on the sphincter of Oddi: a review of the data and therapeutic implications in treating pancreatitisAm J Gastroenterol20019641266127211316181
   PubMed Web of Science ®Google Scholar
• WuSDZhangZHJinJZEffects of narcotic analgesic drugs on human Oddi’s sphincter motilityWorld J Gastroenterol200410192901290415334697
   PubMed Web of Science ®Google Scholar
• CoelhoJCSenningerNRunkelNHerfarthCMessmerKEffect of analgesic drugs on the electromyographic activity of the gastrointestinal tract and sphincter of Oddi and on biliary pressureAnn Surg1986204153583729583
   PubMed Web of Science ®Google Scholar
• SharmaSSSphincter of Oddi dysfunction in patients addicted to opium: an unrecognized entityGastrointest Endosc200255342743011868024
   PubMed Web of Science ®Google Scholar
• BouvierMKirschnerGGonellaJActions of morphine and enkephalins on the internal anal sphincter of the cat: relevance for the physiological role of opiatesJ Auton Nerv Syst19861632192323745778
   PubMedGoogle Scholar
• BurleighDED’MelloANeural and pharmacologic factors affecting motility of the internal anal sphincterGastroenterology19838424094176336709
   PubMed Web of Science ®Google Scholar
• GregersenHBiomechanics of the Gastrointestinal Tract. New Perspectives in MotilityResearch and DiagnosticsLondonSpringer-Verlag200293114
   Google Scholar
• McMahonBPFrøkjaerJBLiaoDKunwaldPDrewesAMGregersenHA new technique for evaluating sphincter function in visceral organs: application of the functional lumen imaging probe (FLIP) for the evaluation of the oesophago-gastric junctionPhysiol Meas200526582383616088071
   PubMed Web of Science ®Google Scholar
• McMahonBPDrewesAMGregersenHFunctional oesophago-gastric junction imagingWorld J Gastroenterol200612182818282416718804
   PubMed Web of Science ®Google Scholar
• AlqudahMMGregersenHDrewesAMMcMahonBPEvaluation of anal sphincter resistance and distensibility in healthy controls using EndoFLIP ©Neurogastroenterol Motil20122412e591e59923072480
   PubMed Web of Science ®Google Scholar
• DiegoLAtayeeRHelmonsPHsiaoGvon GuntenCFNovel opioid antagonists for opioid-induced bowel dysfunctionExpert Opin Investig Drugs201120810471056
   PubMed Web of Science ®Google Scholar
• HerndonCMJacksonKC2ndHallinPAManagement of opioid-induced gastrointestinal effects in patients receiving palliative carePharmacotherapy200222224025011837561
   PubMed Web of Science ®Google Scholar
• LemboACamilleriMChronic constipationN Engl J Med2003349141360136814523145
   PubMed Web of Science ®Google Scholar
• FrantzidesCTCowlesVSalaymehBTekinECondonREMorphine effects on human colonic myoelectric activity in the postoperative periodAm J Surg19921631144148 discussion 148–1491733363
   PubMed Web of Science ®Google Scholar
• TelfordGLCondonRESzurszewskiJHOpioid receptors and the initiation of migrating myoelectric complexes in dogsAm J Physiol19892561 Pt 1G72G772563201
   PubMed Web of Science ®Google Scholar
• De LucaACouparIMInsights into opioid action in the intestinal tractPharmacol Ther19966921031158984506
   PubMed Web of Science ®Google Scholar
• TorresDParrinelloGTrapaneseCLicataGSudden severe abdominal pain after a single low dose of paracetamol/codein in a cholecystectomized patient: learning from a case reportAm J Ther174e133e13419829093
   PubMed Web of Science ®Google Scholar
• SmithKHoppMMundinGLow absolute bioavailability of oral naloxone in healthy subjectsInt J Clin Pharmacol Ther201250536036722541841
   PubMed Web of Science ®Google Scholar
• MeissnerWSchmidtUHartmannMKathRReinhartKOral naloxone reverses opioid-associated constipationPain200084110510910601678
   PubMed Web of Science ®Google Scholar
• VondrackovaDLeyendeckerPMeissnerWAnalgesic efficacy and safety of oxycodone in combination with naloxone as prolonged release tablets in patients with moderate to severe chronic painJ Pain20089121144115418708300
   PubMed Web of Science ®Google Scholar
• BurnessCBKeatingGMOxycodone/Naloxone prolonged-release: a review of its use in the management of chronic pain while counteracting opioid-induced constipationDrugs201474335337524452879
   PubMed Web of Science ®Google Scholar
• LeppertWThe place of oxycodone/naloxone in chronic pain managementContemp Oncol (Pozn)201317212813323788978
   PubMed Web of Science ®Google Scholar
• SykesNPAn investigation of the ability of oral naloxone to correct opioid-related constipation in patients with advanced cancerPalliat Med19961021351448800821
   PubMed Web of Science ®Google Scholar
• LeppertWNew treatment possibilities for opioid-induced bowel dysfunctionPain201315491491149223953125
   PubMed Web of Science ®Google Scholar
• KraftMDMethylnaltrexone, a new peripherally acting mu-opioid receptor antagonist being evaluated for the treatment of postoperative ileusExpert Opin Investig Drugs200817913651377
   PubMed Web of Science ®Google Scholar
• PortenoyRKThomasJMoehl BoatwrightMLSubcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced illness: a double-blind, randomized, parallel group, dose-ranging studyJ Pain Symptom Manage200835545846818440447
   PubMed Web of Science ®Google Scholar
• ThomasJKarverSCooneyGAMethylnaltrexone for opioid-induced constipation in advanced illnessN Engl J Med2008358222332234318509120
   PubMed Web of Science ®Google Scholar
• SchmidtWKAlvimopan* (ADL 8-2698) is a novel peripheral opioid antagonistAm J Surg2001182Suppl 5A27S38S11755894
   PubMed Web of Science ®Google Scholar
• PaulsonDMKennedyDTDonovickRAAlvimopan: an oral, peripherally acting, mu-opioid receptor antagonist for the treatment of opioid-induced bowel dysfunction – a 21-day treatment-randomized clinical trialJ Pain20056318419215772912
   PubMed Web of Science ®Google Scholar
• CamilleriMAlvimopan, a selective peripherally acting mu-opioid antagonistNeurogastroenterol Motil200517215716515787936
   PubMed Web of Science ®Google Scholar
• RobertsMJBentleyMDHarrisJMChemistry for peptide and protein PEGylationAdv Drug Deliv Rev200254445947612052709
   PubMed Web of Science ®Google Scholar
• BelseyJDGeraintMDixonTASystematic review and meta analysis: polyethylene glycol in adults with non-organic constipationInt J Clin Pract201064794495520584228
   PubMed Web of Science ®Google Scholar
• The PubChem Project– [homepage on the Internet]NaloxegolNational Center for Biotechnology Information Available at: http://pubchem.ncbi.nlm.nih.gov/summary/summary.cgi?cid=56959087#itabs-2dAccessed July 10, 2014
   Google Scholar
• WirzSKlaschikEManagement of constipation in palliative care patients undergoing opioid therapy: is polyethylene glycol an option?Am J Hosp Palliat Care200522537538116225360
   PubMedGoogle Scholar
• EldonMSongDNeumannTOral NKTR-118 (oral PEG-naloxol), a PEGylated derivative of naloxone; demonstration of selective peripheral opioid antagonism after oral administrationPoster presented at: The American Academy of Pain Management 18th Annual Clinical MeetingSeptember 27–30, 2007Las Vegas, NV
   Google Scholar
• GottfridssonCCarlsonGLappalainenJSostekMEvaluation of the effect of Naloxegol on cardiac repolarization: a randomized, placebo- and positive-controlled crossover thorough QT/QTc study in healthy volunteersClin Ther201335121876188324238792
   PubMed Web of Science ®Google Scholar
• PaaschenH vanSahnerDMarcantonioAEldonMAResults from a phase 1, double-blind, randomized, placebo-controlled. Multiple-dose study evaluating the safety, tolerability, and pharmacokinetics of oral doses of NKTR-118 (PEG-Naloxol)J Pain200894, Supplement 228 Available from http://www.nektar.com/pdf/pipeline/NKTR-118/NKTR-118_Phase_1_APS_Poster_20080507.pdfAccessed August 19, 201417936076
   PubMed Web of Science ®Google Scholar
• OdinecsASongYHariteSLeeMGKuglerAREldonMANKTR-118, an oral peripheral opioid antagonist, has low potential for drug-drug interactionsPoster presented at: The American College of Clinical Pharmacology 38th Annual MeetingSeptember 13–15, 2009San Antonio, TX
   Google Scholar
• BuiKSheFSostekMThe effects of mild or moderate hepatic impairment on the pharmacokinetics, safety, and tolerability of naloxegolJ Clin Pharmacol Epub2014619
   Google Scholar
• BuiKSheFSostekMThe effects of renal impairment on the pharmacokinetics, safety, and tolerability of naloxegolJ Clin Pharmacol Epub2014619
   Google Scholar
• US Food and Drug AdministrationNaloxegol NDA 204-760 Briefing Document for the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC)Washington, DCUS Food and Drug Administration Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM400209.pdfAccessed August 14, 2014
   Google Scholar
• NeumannTPaaschenH VanMarcantonioASongDKuglerAREldonMAEvaluation of PEG-Naloxol (NKTR-118) as an oral peripheral opioid antagonist in healthy male subjects: a double-blind, placebo-controlled, dose escalation crossover studyPoster presented at: The American College of Clinical Pharmacology 36th Annual MeetingSeptember 9–11, 2007San Francisco, CA
   Google Scholar
• CheyWDWebsterLSostekMLappalainenJBarkerPNTackJNaloxegol for opioid-induced constipation in patients with noncancer painN Engl J Med2014370252387239624896818
   PubMed Web of Science ®Google Scholar
• OlesenAEDrewesAMValidated tools for evaluating opioid-induced bowel dysfunctionAdv Ther201128427929421437762
   PubMed Web of Science ®Google Scholar