Breath-powered sumatriptan dry nasal powder: an intranasal medication delivery system for acute treatment of migraine

References

• Headache Classification Committee of the International Headache Society (IHS)The International Classification of Headache Disorders, 3rd editionCephalalgia2018381121129368949
   PubMed Web of Science ®Google Scholar
• MarmuraMJSilbersteinSDSchwedtTJThe acute treatment of migraine in adults: the American Headache Society evidence assessment of migraine pharmacotherapiesHeadache201555132025600718
   PubMed Web of Science ®Google Scholar
• LoderETriptan therapy in migraineN Engl J Med20103631637020592298
   PubMed Web of Science ®Google Scholar
• GBD 2016 Disease and Injury Incidence and Prevalence CollaboratorsGlobal, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016Lancet2017390101001211125928919117
   PubMed Web of Science ®Google Scholar
• QuickStats: percentage of adults aged ≥18 years who reported having a severe headache or migraine in the past 3 months, by sex and age group – National Health Interview Survey, United States, 2015MMWR2017662465428640794
   PubMed Web of Science ®Google Scholar
• LiptonRBFanningKMSerranoDReedMLCadyRBuseDCIneffective acute treatment of episodic migraine is associated with new-onset chronic migraineNeurology201584768869525609757
   PubMed Web of Science ®Google Scholar
• BeckerWJAcute migraine treatment in adultsHeadache201555677879325877672
   PubMed Web of Science ®Google Scholar
• DiamondSBigalMESilbersteinSLoderEReedMLiptonRBPatterns of diagnosis and acute and preventive treatment for migraine in the United States: results from the American Migraine Prevalence and Prevention studyHeadache200747335536317371352
   PubMed Web of Science ®Google Scholar
• JohnstonMMRapoportAMTriptans for the management of migraineDrugs201070121505151820687618
   PubMed Web of Science ®Google Scholar
• SilbersteinSDPractice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of NeurologyNeurology200055675476210993991
   PubMed Web of Science ®Google Scholar
• Camara-LemarroyCRRodriguez-GutierrezRMonreal-RoblesRMarfil-RiveraAGastrointestinal disorders associated with migraine: a comprehensive reviewWorld J Gastroenterol201622368149816027688656
   PubMed Web of Science ®Google Scholar
• TepperSJRapoportAMThe triptans: a summaryCNS Drugs1999125403417
   Web of Science ®Google Scholar
• IMITREX (sumatriptan succinate) tablets, for oral use [Prescribing information]GlaxoSmithKline Research Triangle ParkNC, USA2013
   Google Scholar
• DixonCMSaynorDAAndrewPDOxfordJBradburyATarbitMHDisposition of sumatriptan in laboratory animals and humansDrug Metab Dispos19932157617697902233
   PubMed Web of Science ®Google Scholar
• DodickDWTriptan nonresponder studies: implications for clinical practiceHeadache200545215616215705122
   PubMed Web of Science ®Google Scholar
• GallagherRMKunkelRMigraine medication attributes important for patient compliance: concerns about side effects may delay treatmentHeadache2003431364312864756
   PubMed Web of Science ®Google Scholar
• CadyRKMunjalSCadyRJManleyHRBrand-SchieberERandomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraineJ Headache Pain20171811728176235
   PubMed Web of Science ®Google Scholar
• DerryCJDerrySMooreRASumatriptan (all routes of administration) for acute migraine attacks in adults – overview of Cochrane reviewsCochrane Database Syst Rev20145CD009108
   PubMed Web of Science ®Google Scholar
• SilbersteinSDMarcusDASumatriptan: treatment across the full spectrum of migraineExpert Opin Pharmacother201314121659166723786565
   PubMed Web of Science ®Google Scholar
• IMITREX (sumatriptan succinate) injection, for subcutaneous use [Prescribing information]GlaxoSmithKline Research Triangle ParkNC, USA2015
   Google Scholar
• Sumavel DosePro (sumatriptan injection), for subcutaneous use [Pre-scribing information]Endo Pharmaceuticals IncMalvern, PA, USA2016
   Google Scholar
• ONZETRA^® Xsail^® (sumatriptan nasal powder) [Prescribing information]Avanir Pharmaceuticals, IncAliso Viejo, CA, USA2016
   Google Scholar
• DjupeslandPGNasal drug delivery devices: characteristics and performance in a clinical perspective – a reviewDrug Deliv Transl Res201331426223316447
   PubMed Web of Science ®Google Scholar
• DjupeslandPGMessinaJCMahmoudRABreath powered nasal delivery: a new route to rapid headache reliefHeadache201353Suppl 2728424024605
   PubMed Web of Science ®Google Scholar
• DjupeslandPGSkrettingANasal deposition and clearance in man: comparison of a bidirectional powder device and a traditional liquid spray pumpJ Aerosol Med Pulm Drug Deliv201225528028922251061
   PubMed Web of Science ®Google Scholar
• FuseauEPetricoulOMooreKHBarrowAIbbotsonTClinical pharmacokinetics of intranasal sumatriptanClin Pharmacokinet2002411180181112190330
   PubMed Web of Science ®Google Scholar
• DuquesnoyCMametJPSumnerDFuseauEComparative clinical pharmacokinetics of single doses of sumatriptan following subcutaneous, oral, rectal and intranasal administrationEur J Pharm Sci199862991049795022
   PubMed Web of Science ®Google Scholar
• DerryCJDerrySMooreRASumatriptan (intranasal route of administration) for acute migraine attacks in adultsCochrane Database Syst Rev20122CD009663
   PubMed Web of Science ®Google Scholar
• ObaidiMOffmanEMessinaJCarothersJDjupeslandPGMahmoudRAImproved pharmacokinetics of sumatriptan with Breath Powered™ nasal delivery of sumatriptan powderHeadache20135381323133323992438
   PubMed Web of Science ®Google Scholar
• LuthringerRDjupeslandPGSheldrakeCDRapid absorption of sumatriptan powder and effects on glyceryl trinitrate model of head-ache following intranasal delivery using a novel bi-directional deviceJ Pharm Pharmacol20096191219122819703372
   PubMed Web of Science ®Google Scholar
• CadyRKMcAllisterPJSpieringsELA randomized, double-blind, placebo-controlled study of breath powered nasal delivery of sumatriptan powder (AVP-825) in the treatment of acute migraine (The TARGET Study)Headache20145518810025355310
   PubMed Web of Science ®Google Scholar
• DjupeslandPGDocekalPCzech Migraine Investigators GroupIntranasal sumatriptan powder delivered by a novel breath-actuated bi-directional device for the acute treatment of migraine: a randomised, placebo-controlled studyCephalalgia201030893394220656704
   PubMed Web of Science ®Google Scholar
• TepperSJCadyRKSilbersteinSAVP-825 breath-powered intra-nasal delivery system containing 22 mg sumatriptan powder vs 100 mg oral sumatriptan in the acute treatment of migraines (The COMPASS Study): a comparative randomized clinical trial across multiple attacksHeadache201555562163525941016
   PubMed Web of Science ®Google Scholar
• SilbersteinSWinnerPKMcAllisterPJEarly onset of efficacy and consistency of response across multiple migraine attacks from the Randomized COMPASS Study: AVP-825 Breath Powered® Exhalation Delivery System (Sumatriptan Nasal Powder) vs Oral SumatriptanHeadache201757686287628497569
   PubMed Web of Science ®Google Scholar
• DaviesGMSantanelloNLiptonRDeterminants of patient satisfaction with migraine therapyCephalalgia200020655456011075838
   PubMed Web of Science ®Google Scholar
• LiptonRBHamelskySWDaynoJMWhat do patients with migraine want from acute migraine treatment?Headache200242Suppl 13911966858
   PubMed Web of Science ®Google Scholar
• SmeltAFLouterMAKiesDAWhat do patients consider to be the most important outcomes for effectiveness studies on migraine treatment? Results of a Delphi studyPLoS One201496e9893324932784
   PubMed Web of Science ®Google Scholar
• FerrariMDGoadsbyPJRoonKILiptonRBTriptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trialsCephalalgia200222863365812383060
   PubMed Web of Science ®Google Scholar
• PierceMOral triptans and nausea: treatment considerations in migraineHeadache201353Suppl 1172023721286
   PubMed Web of Science ®Google Scholar
• LiptonRBMcGinleyJSShulmanKJSilbersteinSDWirthRJBuseDCAVP-825 (sumatriptan nasal powder) reduces nausea compared to sumatriptan tablets: results of the COMPASS Randomized Clinical TrialHeadache201858222924229034453
   PubMed Web of Science ®Google Scholar
• XHANCE^™ (fluticasone propionate) nasal spray, for intranasal use [Prescribing Information] Available from: https://www.xhance.com/wp-content/themes/xhance/assets/pdf/XHANCE_Full_Prescribing_Information.pdf2017Accessed February 27, 2018
   Google Scholar
• OptiNose US, IncResearch & Development Available from: https://www.optinose.com/research-and-development/overview-chart2017Accessed February 27, 2018
   Google Scholar