13,437
Views
0
CrossRef citations to date
0
Altmetric
Systematic Review

Pharmacokinetic Properties of Intranasal and Injectable Formulations of Naloxone for Community use: a Systematic Review

&
Pages 231-245 | Received 06 Nov 2017, Accepted 20 Mar 2018, Published online: 23 Apr 2018

References

  • Centers for Disease Control and Prevention . NCHS data on drug-poisoning deaths ( 2016 ). https://www.cdc.gov/nchs/data/factsheets/factsheet_drug_poisoning.htm .
  • Rudd RA , AleshireN , ZibbellJE , GladdenRM . Increases in drug and opioid overdose deaths – United States, 2000–2014 . MMWR Morb. Mortal. Wkly Rep.64 ( 50–51 ), 1378 – 1382 ( 2016 ).
  • Rudd RA , SethP , DavidF , SchollL . Increases in drug and opioid-involved overdose deaths – United States, 2010–2015 . MMWR Morb. Mortal. Wkly Rep.65 ( 50–51 ), 1445 – 1452 ( 2016 ).
  • Peterson AB , GladdenRM , DelcherCet al. Increases in fentanyl-related overdose deaths – Florida and Ohio, 2013–2015 . MMWR Morb. Mortal. Wkly Rep.65 ( 33 ), 844 – 849 ( 2016 ).
  • Lucyk SN , NelsonLS . Toxicosurveillance in the US opioid epidemic . Int. J. Drug Policy46 , 168 – 171 ( 2017 ).
  • Lucyk SN , NelsonLS . Novel synthetic opioids: an opioid epidemic within an opioid epidemic . Ann. Emerg. Med.69 ( 1 ), 91 – 93 ( 2017 ).
  • Albert M , McCaigLF , UddinS . Emergency Department Visits for Drug Poisoning: United States, 2008–2011 . US Department of Health & Human Services , MD, USA ( 2015 ).
  • Yokell MA , DelgadoMK , ZallerND , WangNE , McGowanSK , GreenTC . Presentation of prescription and nonprescription opioid overdoses to US emergency departments . JAMA Intern. Med.174 ( 12 ), 2034 – 2037 ( 2014 ).
  • Handal KA , SchaubenJL , SalamoneFR . Naloxone . Ann. Emerg. Med.12 ( 7 ), 438 – 445 ( 1983 ).
  • Wermeling DP . Review of naloxone safety for opioid overdose: practical considerations for new technology and expanded public access . Ther. Adv. Drug Saf.6 ( 1 ), 20 – 31 ( 2015 ).
  • Compton WM , VolkowND , ThrockmortonDC , LurieP . Expanded access to opioid overdose intervention: research, practice, and policy needs . Ann. Intern. Med.158 ( 1 ), 65 – 66 ( 2013 ).
  • Wheeler E , JonesTS , GilbertMK , DavidsonPJ . Opioid overdose prevention programs providing naloxone to laypersons – United States, 2014 . MMWR Morb. Mortal. Wkly Rep.64 ( 23 ), 631 – 635 ( 2015 ).
  • Califf RM , WoodcockJ , OstroffS . A proactive response to prescription opioid abuse . N. Engl. J. Med.374 ( 15 ), 1480 – 1485 ( 2016 ).
  • Strang J , McDonaldR , TasB , DayE . Clinical provision of improvised nasal naloxone without experimental testing and without regulatory approval: imaginative shortcut or dangerous bypass of essential safety procedures?Addiction111 ( 4 ), 574 – 582 ( 2016 ).
  • Barton ED , ColwellCB , WolfeTet al. Efficacy of intranasal naloxone as a needleless alternative for treatment of opioid overdose in the prehospital setting . J. Emerg. Med.29 ( 3 ), 265 – 271 ( 2005 ).
  • Kerr D , KellyAM , DietzeP , JolleyD , BargerB . Randomized controlled trial comparing the effectiveness and safety of intranasal and intramuscular naloxone for the treatment of suspected heroin overdose . Addiction104 ( 12 ), 2067 – 2074 ( 2009 ).
  • Weber JM , TatarisKL , HoffmanJD , AksSE , MycykMB . Can nebulized naloxone be used safely and effectively by emergency medical services for suspected opioid overdose?Prehosp. Emerg. Care16 ( 2 ), 289 – 292 ( 2012 ).
  • Rando J , BroeringD , OlsonJE , MarcoC , EvansSB . Intranasal naloxone administration by police first responders is associated with decreased opioid overdose deaths . Am. J. Emerg. Med.33 ( 9 ), 1201 – 1204 ( 2015 ).
  • Fisher R , O’DonnellD , RayB , RusyniakD . Police officers can safely and effectively administer intranasal naloxone . Prehosp. Emerg. Care20 ( 6 ), 675 – 680 ( 2016 ).
  • Doe-Simkins M , WalleyAY , EpsteinA , MoyerP . Saved by the nose: bystander-administered intranasal naloxone hydrochloride for opioid overdose . Am. J. Public Health99 ( 5 ), 788 – 791 ( 2009 ).
  • Edwards ET , EdwardsES , DavisE , MulcareM , WiklundM , KelleyG . Comparative usability study of a novel auto-injector and an intranasal system for naloxone delivery . Pain Ther.4 ( 1 ), 89 – 105 ( 2015 ).
  • Edwards E , EdwardsE , KelleyG , FinkN , DissingerE , ShamesA . Comparative simulated use study of a novel auto-injector and nasal delivery device for naloxone administration . Postgrad. Med.128 ( Suppl. 2 ), 24 – 25 ( 2016 ).
  • EVZIO® (naloxone hydrochloride injection) auto-injector for intramuscular or subcutaneous use, package insert . Kaléo, Inc. , VA, USA ( 2014 ). https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=df501ed0-c0f4-11e3-8a33-0800200c9a66&type=display .
  • EVZIO® (naloxone hydrochloride injection) auto-injector for intramuscular or subcutaneous use 2mg, package insert . Kaléo, Inc. , VA, USA ( 2016 ). https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=5fbe8d17-a72f-406d-a736-48e61620f9d8&type=display .
  • NARCAN® (naloxone hydrochloride) nasal spray, package insert . Adapt Pharma, Inc. , PA, USA ( 2017 ). https://www.narcan.com/pdf/NARCAN-Prescribing-Information.pdf .
  • US FDA . Current Good Manufacturing Practice Requirements for Combination Products . US FDA , MD, USA ( 2017 ). http://www.fda.gov/RegulatoryInformation/Guidances/ucm126198.htm .
  • Elzey MJ , FudinJ , EdwardsES . Take-home naloxone treatment for opioid emergencies: a comparison of routes of administration and associated delivery systems . Expert Opin. Drug Deliv.16 , 1 – 14 ( 2016 ).
  • US FDA . Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development . US FDA , MD, USA ( 2016 ). https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM484345.pdf .
  • Birmingham LE , NielsonJA . An increase in per-patient naloxone requirements in an opioid epidemic . Am. J. Emerg. Med.35 ( 12 ), 1958 – 1959 ( 2017 ).
  • Faul M , LurieP , KinsmanJM , DaileyMW , CrabaughC , SasserSM . Multiple naloxone administrations among emergency medical service providers is increasing . Prehosp. Emerg. Care21 ( 4 ), 411 – 419 ( 2017 ).
  • Edwards ES , GunnR , KelleyG , SmithA , GoldwaterR . Naloxone 0.4 mg bioavailability following a single injection with a novel naloxone auto-injector, EVZIO®, in healthy adults, with reference to a 1 mL standard syringe and intramuscular needle . Presented at : American Academy of Pain Medicine . MD, USA , 19–22 March 2015 .
  • Krieter P , ChiangN , GyawSet al. Pharmacokinetic properties and human use characteristics of an FDA-approved intranasal naloxone product for the treatment of opioid overdose . J. Clin. Pharmacol.56 ( 10 ), 1243 – 1253 ( 2016 ).
  • Edwards ES , KesslerCL , KelleyG , GapasinA , MardariG , GoldwaterR . Pharmacokinetics of 2.0 mg intranasal and intramuscular naloxone HCl administration and the impact of vasoconstrictor use on the bioavailability of intranasal naloxone HCl . Presented at : American Academy of Pain Medicine . CA, USA , 18–21 February 2016 .
  • Dowling J , IsbisterGK , KirkpatrickCM , NaidooD , GraudinsA . Population pharmacokinetics of intravenous, intramuscular, and intranasal naloxone in human volunteers . Ther. Drug Monit.30 ( 4 ), 490 – 496 ( 2008 ).
  • McDonald R , LorchU , WoodwardJet al. Pharmacokinetics of concentrated naloxone nasal spray for opioid overdose reversal: Phase I healthy volunteer study . Addiction113 ( 3 ), 484 – 493 ( 2017 ).
  • Tylleskar I , SkulbergAK , NilsenT , SkarraS , JansookP , DaleO . Pharmacokinetics of a new, nasal formulation of naloxone . Eur. J. Clin. Pharmacol.73 ( 5 ), 555 – 562 ( 2017 ).
  • Strang J , LorchU , McDonaldRet al. A concentrated naloxone nasal spray for opioid overdose reversal: a pharmacokinetic study in healthy volunteers . Presented at : Society for the Study of Addiction Annual Conference . Newcastle upon Tyne, UK , 10–11 November 2016 .
  • Mundin G , McDonaldR , SmithK , HarrisS , StrangJ . Pharmacokinetics of concentrated naloxone nasal spray over first 30 minutes post-dosing: analysis of suitability for opioid overdose reversal . Addiction112 ( 9 ), 1647 – 1652 ( 2017 ).
  • Vanky E , HellmundtL , BondessonU , EksborgS , LundebergS . Pharmacokinetics after a single dose of naloxone administered as a nasal spray in healthy volunteers . Acta Anaesthesiol. Scand.61 ( 6 ), 636 – 460 ( 2017 ).
  • Gufford BT , AinslieGR , WhiteJRJret al. Comparison of a new intranasal naloxone formulation to intramuscular naloxone: results from hypothesis-generating small clinical studies . Clin. Transl. Sci.10 ( 5 ), 380 – 386 ( 2017 ).
  • Wermeling DP . A response to the opioid overdose epidemic: naloxone nasal spray . Drug Deliv. Transl. Res.3 ( 1 ), 63 – 74 ( 2013 ).
  • Robinson A , WermelingDP . Intranasal naloxone administration for treatment of opioid overdose . Am. J. Health Syst. Pharm.71 ( 24 ), 2129 – 2135 ( 2014 ).
  • van Dorp E , YassenA , DahanA . Naloxone treatment in opioid addiction: the risks and benefits . Expert Opin. Drug Saf.6 ( 2 ), 125 – 132 ( 2007 ).
  • McDonald R , Danielsson GlendeO , DaleO , StrangJ . International patent applications for non-injectable naloxone for opioid overdose reversal: exploratory search and retrieve analysis of the PatentScope database . Drug Alcohol Rev.37 ( 2 ), 205 – 215 ( 2017 ).
  • Strang J , McDonaldR , AlqurshiA , RoyallP , TaylorD , ForbesB . Naloxone without the needle – systematic review of candidate routes for non-injectable naloxone for opioid overdose reversal . Drug Alcohol Depend.163 , 16 – 23 ( 2016 ).
  • Rzasa Lynn R , GalinkinJL . Naloxone dosage for opioid reversal: current evidence and clinical implications . Ther. Adv. Drug Saf.9 ( 1 ), 63 – 88 ( 2018 ).
  • van der Schier R , RoozekransM , van VelzenM , DahanA , NiestersM . Opioid-induced respiratory depression: reversal by non-opioid drugs . F1000Prime Rep.6 , 79 ( 2014 ).
  • Investor News . Indivior receives complete response letter from FDA not approving naloxone nasal spray new drug application for opioid overdose . Indivior Inc. , Slough, UK ( 2015 ). http://www.indivior.com/investor-news/indivior-receives-complete-response-letter-from-fda-not-approving-naloxone-nasal-spray-new-drug-application-for-opioid-overdose .
  • Boyer EW . Management of opioid analgesic overdose . N. Engl. J. Med.367 ( 2 ), 146 – 155 ( 2012 ).
  • Clarke SF , DarganPI , JonesAL . Naloxone in opioid poisoning: walking the tightrope . Emerg. Med. J.22 ( 9 ), 612 – 616 ( 2005 ).
  • US FDA . Joint Meeting of Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee . US FDA , MD, USA ( 2016 ). http://prescribetoprevent.org/wp2015/wp-content/uploads/Naloxone-product-chart.17_04_14.pdf .
  • Fiore K . FDA splits on naloxone dose . MedPage Today ( 2016 ). http://medpagetoday.com/neurology/generalneurology/60632 .
  • EVZIO® (naloxone HCI injection) 2 mg auto-injector ( 2016 ). https://evzio.com/hcp/ .
  • NARCAN® (naloxone HCI) nasal spray 2 mg approved by US FDA . Adapt Pharma, Inc. , PA, USA ( 2017 ). http://adaptpharma.com/adapt_press_release/january-25–2017-narcan-nasal-spray-2mg-approved-by-us-food-and-drug-administration/ .
  • Avetian GK , FiutyP , MazzellaS , KoppaD , HeyeV , HebbarP . Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations . Curr. Med. Res. Opin.34 ( 4 ), 573 – 576 ( 2017 ).
  • Kestler A , BuxtonJ , MecklingGet al. Factors associated with participation in an emergency department–based take-home naloxone program for at-risk opioid users . Ann. Emerg. Med.69 ( 3 ), 340 – 346 ( 2017 ).
  • Gianutsos G . Expanding access to naloxone: role of the pharmacist . US Pharmacist ( 2016 ). https://www.uspharmacist.com/ce/expanding-access-to-naloxone-role .
  • Weaver L , PalombiL , BastianelliKMS . Naloxone administration for opioid overdose reversal in the prehospital setting: implications for pharmacists . J. Pharm. Pract.31 ( 1 ), 91 – 98 ( 2018 ).
  • Bailey AM , WermelingDP . Naloxone for opioid overdose prevention: pharmacists’ role in community-based practice settings . Ann. Pharmacother.48 ( 5 ), 601 – 606 ( 2014 ).
  • Dowell D , HaegerichTM , ChouR . CDC guideline for prescribing opioids for chronic pain – United States, 2016 . JAMA315 ( 15 ), 1624 – 1645 ( 2016 ).
  • Lyons MS , LindsellCJ , LedyardHK , FramePT , TrottAT . Health department collaboration with emergency departments as a model for public health programs among at-risk populations . Public Health Rep.120 ( 3 ), 259 – 265 ( 2005 ).
  • Guy GP Jr , ZhangK , BohmMKet al. Vital signs: changes in opioid prescribing in the United States, 2006–2015 . MMWR Morb. Mortal. Wkly Rep.66 ( 26 ), 697 – 704 ( 2017 ).