Intranasal Sumatriptan Powder Delivered by a Novel Breath Actuated Bi-Directional Device for the Acute Treatment of Migraine: A Randomised, Placebo-Controlled Study

PG Djupesland, P Docˇekal and the Czech Migraine Investigators Group
Cephalalgia OnlineFirst, published on March 17, 2010 as doi:10.1177/0333102409359314



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.