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

• Published in: Cephalalgia Vol. 30; no. 8; pp. 933 - 942
• Main Authors: Djupesland, PG, Dočekal, P
• Format: Journal Article
• Language: English
• Published: UK SAGE Publications 01.08.2010
• Subjects: Administration, Inhalation; Administration, Intranasal; Adult; Female; Humans; Male; Middle Aged; Migraine Disorders - drug therapy; Powders - administration & dosage; Sumatriptan - administration & dosage; Sumatriptan - adverse effects; Vasoconstrictor Agents - administration & dosage; Vasoconstrictor Agents - adverse effects; Young Adult; bi-directional nasal delivery; Sumatriptan; migraine
• ISSN: 0333-1024; 1468-2982; 1468-2982
• DOI: 10.1177/0333102409359314

Introduction: Intranasal sumatriptan is an option for the treatment of migraine; however, nasal delivery using conventional spray pumps is suboptimal. Methods: 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. Results: 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%). Conclusions: Sumatriptan nasal powder administered using the new device during a migraine attack was effective and well tolerated.