Intranasal sumatriptan powder delivered by a novel breath-actuated bi-directional device for the acute treatment of migraine: A randomised, placebo-controlled study

Cephalalgia : an International Journal of Headache
Per G DjupeslandCzech Migraine Investigators Group

Abstract

Intranasal sumatriptan is an option for the treatment of migraine; however, nasal delivery using conventional spray pumps is suboptimal. Adult subjects (n = 117) with migraine were enrolled in a multicentre, randomised, double-blind, parallel group, placebo-controlled study. A single migraine attack was treated in-clinic with sumatriptan 10 mg, sumatriptan 20 mg or placebo administered intranasally by a novel bi-directional powder delivery device when migraine was moderate or severe. A greater proportion of subjects who received sumatriptan were pain-free at 120 minutes compared with those who received placebo (10 mg/20 mg sumatriptan vs. placebo = 54%/57% vs. 25%, P < .05). Significant benefits were also observed for pain relief at 120 minutes (84%/80% vs. 44%, P < .001/.01) and as early as 60 minutes (73%/74% vs. 38%, P < .01) and for 48 hours sustained pain-free (P < .05). Treatment-related adverse events were rare, with a metallic taste being the most commonly reported (10%/13%). Sumatriptan nasal powder administered using the new device during a migraine attack was effective and well tolerated.

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Citations

May 6, 2011·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·A Rapoport
Jun 1, 2012·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·Alan M Rapoport
May 25, 2013·Neurological Sciences : Official Journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology·Abraham J Nagy, Alan M Rapoport
Jun 29, 2011·The Journal of Headache and Pain·Peer Carsten Tfelt-Hansen
Jul 11, 2013·CNS Drugs·Sarah Vollbracht, Alan M Rapoport
Jan 15, 2013·Drug Delivery and Translational Research·Per Gisle Djupesland
Mar 13, 2014·Cephalalgia : an International Journal of Headache·P J GoadsbyK A Simmons
Dec 16, 2016·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Jinxiang XiYue Zhou
May 3, 2018·Healthcare Management Forum·Paul G Swingle, Elizabeth Hartney
May 3, 2018·Healthcare Management Forum·Elizabeth Hartney
Feb 18, 2012·The Cochrane Database of Systematic Reviews·Christopher J DerryR Andrew Moore
Jan 19, 2012·Journal of Aerosol Medicine and Pulmonary Drug Delivery·Per Gisle Djupesland, Arne Skretting
Feb 17, 2018·Cephalalgia : an International Journal of Headache·Peer Tfelt-HansenThien Phu Do
Feb 5, 2019·Expert Opinion on Drug Metabolism & Toxicology·Chiara LupiAndrea Negro
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Sep 30, 2016·Drugs·Zaina T Al-Salama, Lesley J Scott
Aug 29, 2021·Pharmaceutics·Dipy M VasaPeter L D Wildfong

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