Breath powered nasal delivery: A new route to rapid headache relief

Headache

Volumn 53, Issue SUPPL.2, 2013, Pages 72-84

  Djupesland, Per G ^a   Messina, John C ^b   Mahmoud, Ramy A ^a  

^a OptiNose US Inc   (United States)

^b OptiNose AS   (Norway)

Author keywords

Absorption; Drug delivery; Migraine; Nasal; Powder; Sumatriptan

Indexed keywords

ABSORPTION; DRUG DELIVERY; MIGRAINE; NASAL; POWDER; SUMATRIPTAN;

ADMINISTRATION, INTRANASAL; ANALGESICS; ANIMALS; DRUG DELIVERY SYSTEMS; HEADACHE; HUMANS; NASAL MUCOSA; RESPIRATION;

EID: 84893924603     PISSN: 00178748     EISSN: 15264610     Source Type: Journal    
DOI: 10.1111/head.12186     Document Type: Article

References (47)

1. Davies GM, Santanello N, Lipton R. Determinants of patient satisfaction with migraine therapy. Cephalalgia. 2000;20: 554-560.
2. Dowson A, Bundy M, Salt R, Kilminster S. Patient preference for triptan formulations: A prospective study with zolmitriptan. Headache. 2007;47: 1144-1151.
3. Aurora SK, Papapetropoulos S, Kori SH, Kedar A, Abell TL. Gastric stasis in migraineurs: Etiology, characteristics, and clinical and therapeutic implications. Cephalalgia. 2013;33: 408-415.
4. Thomsen LL, Dixon R, Lassen LH, et al. 311C90 (Zolmitriptan), a novel centrally and peripheral acting oral 5-hydroxytryptamine-1D agonist: Acomparison of its absorption during a migraine attack and in a migraine-free period. Cephalalgia. 1996; 16: 270-275.
5. Sramek JJ, Hussey EK, Clements B, Cutler NR.Oral sumatriptan pharmacokinetics in the migraine state. Clin Drug Investig. 1999;17: 137-144.
6. Ferrari A, Pinetti D, Bertolini A, Coccia C, Sternieri E. Interindividual variability of oral sumatriptan pharmacokinetics and of clinical response in migraine patients. Eur J Clin Pharmacol. 2008; 64: 489-495.
7. Mathew R, Andreou AP, Chami L, et al. Immunohistochemical characterization of calcitonin generelated peptide in the trigeminal system of the familial hemiplegic migraine 1 knock-in mouse. Cephalalgia. 2011;31: 1368-1380.
8. Djupesland PG.Nasal drug delivery devices: Characteristics and performance in a clinical perspective-a review. Drug Deliv Transl Res. 2013;3: 42-62.
9. Vause C, Bowen E, Spierings E, Durham P. Effect of carbon dioxide on calcitonin gene-related peptide secretion from trigeminal neurons. Headache. 2007; 47: 1385-1397.
10. Goadsby PJ. Sphenopalatine (pterygopalatine) ganglion stimulation and cluster headache: New hope for ye who enter here. Cephalalgia. 2013;33: 813-815.
11. Schoenen J, Vandersmissen B, Jeangette S, et al. Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial. Neurology. 2013;80: 697-704.
12. Schoenen J, Jensen RH, Lanteri-Minet M, et al. Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: A randomized, sham-controlled study. Cephalalgia. 2013;33: 816-830.
13. Ivanusic JJ, Kwok MM, Jennings EA. Peripheral targets of 5-HT(1D) receptor immunoreactive trigeminal ganglion neurons. Headache. 2011;51: 744-751.
14. Barbanti P, Fabbrini G, Pesare M, Vanacore N, Cerbo R. Unilateral cranial autonomic symptoms in migraine. Cephalalgia. 2002;22: 256-259.
15. Cady RK, Vause CV, Ho TW, Bigal ME, Durham PL. Elevated saliva calcitonin gene-related peptide levels during acute migraine predict therapeutic response to rizatriptan. Headache. 2009;49: 1258-1266.
16. Bellamy JL, Cady RK, Durham PL. Salivary levels of CGRP and VIP in rhinosinusitis and migraine patients. Headache. 2006;46: 24-33.
17. Casale TB, Romero FA, Spierings EL. Intranasal noninhaled carbon dioxide for the symptomatic treatment of seasonal allergic rhinitis. J Allergy Clin Immunol. 2008;121: 105-109.
18. Spierings E. Abortive treatment of migraine headache with non-inhaled, intranasal carbon dioxide: A randomized, double-blind, placebo-controlled, parallel-grpup study. Headache. 2005;S78(Suppl.): 809.
19. Kotan D, Tatar A, Aygul R, Ulvi H. Assessment of nasal parameters in determination of olfactory dysfunction in Parkinson's disease. J Int Med Res. 2013;41: 334-339.
20. Van der Schueren BJ, Verbrugge FH, Verbesselt R, Van Hecken A, Depre M, de Hoon JN. No arguments for increased endothelial nitric oxide synthase activity in migraine based on peripheral biomarkers. Cephalalgia. 2010;30: 1354-1365.
21. Olesen J, Thomsen LL, Lassen LH, Olesen IJ. The nitric oxide hypothesis of migraine and other vascular headaches. Cephalalgia. 1995;15: 94-100.
22. Messlinger K, Lennerz JK, Eberhardt M, Fischer MJ.CGRP and NO in the trigeminal system: Mechanisms and role in headache generation. Headache. 2012;52: 1411-1427.
23. Rapoport AM, Bigal ME, Tepper SJ, Sheftell FD. Intranasal medications for the treatment of migraine and cluster headache. CNS Drugs. 2004;18: 671-685.
24. Maizels M, Geiger AM. Intranasal lidocaine for migraine: A randomized trial and open-label followup. Headache. 1999;39: 543-551.
25. Kudrow L, Kudrow DB, Sandweiss JH. Rapid and sustained relief of migraine attacks with intranasal lidocaine: Preliminary findings. Headache. 1995;35: 79-82.
26. Hardebo JE, Elner A. Nerves and vessels in the pterygopalatine fossa and symptoms of cluster headache. Headache. 1987;27: 528-532.
27. Ryan R, Elkind A, Baker CC, Mullican W, DeBussey S, Asgharnejad M. Sumatriptan nasal spray for the acute treatment of migraine. Results of two clinical studies. Neurology. 1997;49: 1225-1230.
28. Gawel M, Aschoff J, May A, Charlesworth BR. Zolmitriptan 5 mg nasal spray: Efficacy and onset of action in the acute treatment of migraine -results from phase 1 of the REALIZE Study. Headache. 2005;45: 7-16.
29. Charlesworth BR, Dowson AJ, Purdy A, Becker WJ, Boes-Hansen S, Farkkila M. Speed of onset and efficacy of zolmitriptan nasal spray in the acute treatment of migraine: A randomised, double-blind, placebo-controlled, dose-ranging study versus zolmitriptan tablet. CNS Drugs. 2003;17: 653-667.
30. Goadsby PJ, Yates R. Zolmitriptan intranasal: A review of the pharmacokinetics and clinical efficacy. Headache. 2006;46: 138-149.
31. Duquesnoy C, Mamet JP, Sumner D, Fuseau E. Comparative clinical pharmacokinetics of single doses of sumatriptan following subcutaneous, oral, rectal and intranasal administration. Eur J Pharm Sci. 1998;6: 99-104.
32. Kagedal M,Zingmark PH, Hedlund C,Yates R.True nasopharyngeal absorption of zolmitriptan after administration via nasal spray in healthy.Am J Drug Deliv. 2005;3: 133-140.
33. Fuseau E, Petricoul O, Moore KH, Barrow A, Ibbotson T. Clinical pharmacokinetics of intranasal sumatriptan. Clin Pharmacokinet. 2002;41: 801-811.
34. Fox AW. Onset of effect of 5-HT1B/1D agonists: A model with pharmacokinetic validation. Headache. 2004;44: 142-147.
35. Djupesland PG, Skretting A. Nasal deposition and clearance in man: Comparison of a bidirectional powder device and a traditional liquid spray pump. J Aerosol Med Pulm Drug Deliv. 2012;25: 280-289.
36. Aggarwal R, Cardozo A, Homer JJ. The assessment of topical nasal drug distribution. Clin Otolaryngol Allied Sci. 2004;29: 201-205.
37. Merkus P, Ebbens FA, Muller B, Fokkens WJ. Influence of anatomy and head position on intranasal drug deposition. Eur Arch Otorhinolaryngol. 2006; 263: 827-832.
38. Djupesland PG, Skretting A, Winderen M, Holand T. Bi-directional nasal delivery of aerosols can prevent lung deposition. J Aerosol Med. 2004;17: 249-259.
39. Skretting A, Djupesland PG. A new method for scintigraphic quantification of deposition and clearance in anatomical regions of the human nose. Nucl Med Commun. 2009;30: 629-638.
40. Luthringer R, Djupesland PG, Sheldrake CD, et al. Rapid absorption of sumatriptan powder and effects on glyceryl trinitrate model of headache following intranasal delivery using a novel bi-directional device. J Pharm Pharmacol. 2009;61: 1219-1228.
41. Obaidi M, Offman E, Messina J, Carothers J, Djupesland P, Mahmoud R. Improved pharmacokinetics of sumatriptan with Breath Powered™ nasal delivery of sumatriptan powder. Headache 2013 (in press).
42. Salonen R, Ashford E, Dahlof C, et al. Intranasal sumatriptan for the acute treatment of migraine. International Intranasal Sumatriptan Study Group. J Neurol. 1994;241: 463-469.
43. Djupesland PG, Docekal P. Intranasal sumatriptan powder delivered by a novel breath-actuated bi-directional device for the acute treatment of migraine: A randomised, placebo-controlled study. Cephalalgia. 2010;30: 933-942.
44. Cady R, Messina J, Carothers J, Mahmoud R. Efficacy and safety of a novel Breath-Powered™ Powder sumatriptan intranasal treatment for acute migraine. Headache. 2013; (Suppl.): Abstract (in press).
45. Moller W, Schuschnig U, Khadem Saba G, et al. Pulsating aerosols for drug delivery to the sinuses in healthy volunteers. Otolaryngol Head Neck Surg. 2010;142: 382-388.
46. Eby GA. Strong humming for one hour daily to terminate chronic rhinosinusitis in four days: A case report and hypothesis for action by stimulation of endogenous nasal nitric oxide production. Med Hypotheses. 2006;66: 851-854.
47. Suren M, Kaya Z, Ozkan F, Erkorkmaz U, Arici S, Karaman S. Comparison of the use of the Valsalva maneuver and the eutectic mixture of local anesthetics (EMLA((R)))to relieve venipuncture pain: Arandomized controlled trial. J Anesth. 2013;27(3): 407-411.