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, OptiNose AS, Oslo, Norway; P Docˇekal, Department of Neurology, Charles University in Prague, Czech Republic; The Czech Migraine Investigators Group

Introduction

Intranasal sumatriptan is an option for the treatment of migraine; however, nasal delivery using conventional spray pumps is suboptimal.

Methods

• Adult subjects (n1/4117) 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. placebo1/454%/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.

Clinical Data

Data was presented at the 50th Annual Scientific Meeting of the American Headache Society in Boston, US in June 2008.