556
Views
4
CrossRef citations to date
0
Altmetric
Drug Profile

AVP-825: a novel intranasal delivery system for low-dose sumatriptan powder in the treatment of acute migraine

Pages 821-832 | Received 15 Aug 2016, Accepted 05 Jun 2017, Published online: 03 Jul 2017

References

  • Burch RC, Loder S, Loder E, et al. The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies. Headache. 2015;55:21–34.
  • Pavlovic JM, Stewart WF, Bruce CA, et al. Burden of migraine related to menses: results from the AMPP study. J Headache Pain. 2015;16:24.
  • Silberstein SD, Silberstein T, Sheiner E, et al. Considerations for management of migraine symptoms in the primary care setting. Postgrad Med. 2016;155:1–14.
  • Silberstein SD. Considerations for management of migraine symptoms in the primary care setting. Postgrad Med. 2016;128:523–537.
  • Digre KB, Brennan KC. Shedding light on photophobia. J Neuroophthalmol. 2012;32:68–81.
  • Main A, Dowson A, Gross M. Photophobia and phonophobia in migraineurs between attacks. Headache. 1997;37:492–495.
  • Lipton RB, Buse DC, Saiers J, et al. Frequency and burden of headache-related nausea: results from the American Migraine Prevalence and Prevention (AMPP) study. Headache. 2013;53:93–103.
  • Stovner L, Hagen K, Jensen R, et al. The global burden of headache: a documentation of headache prevalence and disability worldwide. Cephalalgia: Int J Headache. 2007;27:193–210.
  • Steiner TJ, Stovner LJ, Birbeck GL. Migraine: the seventh disabler. Headache. 2013;53:227–229.
  • Buse DC, Lipton RB. Global perspectives on the burden of episodic and chronic migraine. Cephalalgia: Int J Headache. 2013;33:885–890.
  • Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68:343–349.
  • Stokes M, Becker WJ, Lipton RB, et al. Cost of health care among patients with chronic and episodic migraine in Canada and the USA: results from the International Burden of Migraine Study (IBMS). Headache. 2011;51:1058–1077.
  • Bloudek LM, Stokes M, Buse DC, et al. Cost of healthcare for patients with migraine in five European countries: results from the International Burden of Migraine Study (IBMS). J Headache Pain. 2012;13:361–378.
  • Blumenfeld AM, Varon SF, Wilcox TK, et al. Disability, HRQoL and resource use among chronic and episodic migraineurs: results from the International Burden of Migraine Study (IBMS). Cephalalgia: Int J Headache. 2011;31:301–315.
  • Buse DC, Scher AI, Dodick DW, et al. Impact of migraine on the family: perspectives of people with migraine and their spouse/domestic partner in the CaMEO Study. Mayo Clinic proceedings 2016.
  • Lipton RB, Diamond S, Reed M, et al. Migraine diagnosis and treatment: results from the American Migraine Study II. Headache. 2001;41:638–645.
  • Lipton RB, Scher AI, Kolodner K, et al. Migraine in the United States: epidemiology and patterns of health care use. Neurology. 2002;58:885–894.
  • Gilmore B, Michael M. Treatment of acute migraine headache. Am Fam Physician. 2011;83:271–280.
  • Silberstein SD, McCrory DC. Ergotamine and dihydroergotamine: history, pharmacology, and efficacy. Headache. 2003;43:144–166.
  • Kassem AA. Formulation approaches of triptans for management of migraine. Curr Drug Deliv. 2016;13(6):882–898.
  • Dahlof C. Sumatriptan: pharmacological basis and clinical results. Curr Med Res Opin. 2001;17 Suppl 1:s35–45.
  • Rothrock JF, Cady RK, Aurora SK, et al. Needle-free subcutaneous sumatriptan for triptan users requiring a change in migraine therapy: efficacy and impact on patient-rated functionality, satisfaction, and confidence. Curr Med Res Opin. 2011;27:2185–2191.
  • Yang LP. Sumatriptan/naproxen sodium: a review of its use in adult patients with migraine. Drugs. 2013;73:1339–1355.
  • Johnston MM, Rapoport AM. Triptans for the management of migraine. Drugs. 2010;70:1505–1518.
  • URGENT – ZECUITY® (SUMATRIPTAN IONTOPHORETIC TRANSDERMAL SYSTEM) SUSPENSION OF MARKETING [online]. Available from: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM506332.pdf.
  • Duquesnoy C, Mamet JP, Sumner D, et al. Comparative clinical pharmacokinetics of single doses of sumatriptan following subcutaneous, oral, rectal and intranasal administration. Eur J Pharm Sci. 1998;6:99–104.
  • Derry CJ, Derry S, Moore RA. Sumatriptan (all routes of administration) for acute migraine attacks in adults - overview of Cochrane reviews. Cochrane Database Syst Rev. 2014;5:CD009108.
  • Worthington I. Delivery systems for acute migraine medications. Can Fam Physician. 2001;47:322–329.
  • Worthington I, Pringsheim T, Gawel MJ, et al. Canadian Headache Society Guideline: acute drug therapy for migraine headache. Can J Neurological Sci. 2013;40:S1–s80.
  • Aurora SK, Kori SH, Barrodale P, et al. Gastric stasis in migraine: more than just a paroxysmal abnormality during a migraine attack. Headache. 2006;46:57–63.
  • Silberstein SD. Migraine symptoms: results of a survey of self-reported migraineurs. Headache. 1995;35:387–396.
  • Lipton RB, Pascual J, Goadsby PJ, et al. Effect of rizatriptan and other triptans on the nausea symptom of migraine: a post hoc analysis. Headache. 2001;41:754–763.
  • Derry CJ, Derry S, Moore RA. Sumatriptan (subcutaneous route of administration) for acute migraine attacks in adults. Cochrane Database Syst Rev. 2012;2:CD009665.
  • Djupesland PG. Nasal drug delivery devices: characteristics and performance in a clinical perspective-a review. Drug Deliv Transl Res. 2013;3:42–62.
  • Djupesland PG, Messina JC, Mahmoud RA. The nasal approach to delivering treatment for brain diseases: an anatomic, physiologic, and delivery technology overview. Ther Deliv. 2014;5:709–733.
  • 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.
  • Djupesland PG, Skretting A, Winderen M, et al. Breath actuated device improves delivery to target sites beyond the nasal valve. Laryngoscope. 2006;116:466–472.
  • Djupesland PG, Skretting A, Windern M, et al. A novel concept for nasal delivery of aerosols can prevent lung inhalation. Aerosol Med. 2004;17:249–259.
  • Lochhead JJ, Thorne RG. Intranasal delivery of biologics to the central nervous system. Adv Drug Deliv Rev. 2012;64:614–628.
  • Charlesworth BR, Dowson AJ, Purdy A, et al. 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.
  • Ryan R, Elkind A, Baker CC, et al. Sumatriptan nasal spray for the acute treatment of migraine: results of two clinical studies. Neurology. 1997;49:1225–1230.
  • Goadsby PJ, Yates R. Zolmitriptan intranasal: a review of the pharmacokinetics and clinical efficacy. Headache. 2006;46:138–149.
  • Fuseau E, Petricoul O, Moore KH, et al. Clinical pharmacokinetics of intranasal sumatriptan. Clin Pharmacokinet. 2002;41:801–811.
  • 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.
  • Obaidi M, Offman E, Messina J, et al. Improved pharmacokinetics of sumatriptan with Breath Powered nasal delivery of sumatriptan powder. Headache. 2013;53:1323–1333.
  • Djupesland PG, Docekal P. Czech Migraine Investigators G. Intranasal sumatriptan powder delivered by a novel breath-actuated bi-directional device for the acute treatment of migraine: a randomised, placebo-controlled study. Cephalalgia: Int J Headache. 2010;30:933–942.
  • Cady RK, McAllister PJ, Spierings EL, et al. A 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). Headache. 2014;55:88–100.
  • Tepper SJ, Cady RK, Silberstein S, et al. AVP-825 breath-powered intranasal 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 attacks. Headache. 2015;55:621–635.
  • Silberstein S, Winner PK, McAllister PJ, et al. Early 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 sumatriptan. Headache. 2017 May 11. [Epub ahead of print]. doi:10.1111/head.13105
  • Cady R, Djupesland P, Mahmoud R, et al. Pooled analyses of randomized, double-blind, placebo-controlled studies of a breath powered™ nasal delivery system containing 22 mg sumatriptan Powder (AVP-825) in the treatment of episodic migraine. Neurology. 2015;84(14 Suppl):P1.315.
  • Tepper SJ. Clinical implications for breath-powered powder sumatriptan intranasal treatment. Headache. 2013;53:1341–1349.
  • McGinley J, Shulman K, Yedigarova L, et al. Characterizing the most common AEs following treatment with AVP-825: exploring abnormal taste and nasal discomfort across multiple attacks in COMPASS study. Presented at the annual meeting of the American Headache Society. San Diego, CA 2016.
  • Feleppa M, Sheftell FD, Ciannella L, et al. A new questionnaire for assessment of adverse events associated with triptans: methods of assessment influence the results. Preliminary results. J Headache Pain. 2004;5:S112–S116.
  • Feleppa M, Apice G, D’Alessio A, et al. Tolerability of acute migraine medications: influence of methods of assessment and relationship with headache attributes. Cephalalgia: Int J Headache. 2008;28:1012–1016.
  • Sheftell FD, Feleppa M, Tepper SJ, et al. Patterns of use of triptans and reasons for switching them in a tertiary care migraine population. Headache. 2004;44:661–668.
  • Giamberardino MA, Martelletti P. Emerging drugs for migraine treatment. Expert Opin Emerg Drugs. 2015;20:137–147.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.