Abstract Details

Title Randomized, Double-Blind, Pilot Study Comparing 3 Mg Subcutaneous Sumatriptan With 6 Mg Subcutaneous Sumatriptan Using DFN-11 Autoinjector for the Acute Treatment Of Rapidly-Escalating Migraine Attacks

Topic Headache

Presentation(s) P1 - Poster Session 1 (5:30 PM-6:30 PM)

Poster/Presentation
Number 13-007

Objective

To compare 3 mg and 6 mg subcutaneous (SC) sumatriptan using the DFN-11 autoinjector for the acute treatment

of rapidly escalating migraine attacks.

Background

A 6 mg dose of SC sumatriptan is currently considered the fastest and most efficacious acute treatment for migraine, but it is not tolerated by all patients. SC sumatriptan 3 mg may provide improved tolerability while maintaining efficacy.

Design/Methods

This randomized, double-blind, crossover study compared the efficacy and tolerability of 3 mg SC sumatriptan with 6 mg SC sumatriptan in 20 adults with a history of moderate to severe migraine attacks. Subjects were randomized (1:1) to treat each of two attacks with either a DFN-11 plus matching placebo autoinjector (total 3 mg dose) or two DFN-11 autoinjectors (total 6 mg dose). The primary endpoint was pain freedom at 1 hour.

Results The proportion of subjects pain free at 1 hour postdose was similar with 3 mg and 6 mg SC sumatriptan (50% vs 52.6%, P = .87). Other outcome measures were comparable for 3 mg and 6 mg SC sumatriptan, including pain relief; reductions in migraine pain intensity; and relief from nausea, photophobia, or phonophobia. The incidence of adverse events (3 mg, 44%; 6 mg, 56%, P = .60) was similar with both doses. Triptan sensations affected both doses, with a reported duration of 24 minutes with 3 mg and 64 minutes with 6 mg SC sumatriptan (P = .43). Chest pain affected 2 subjects (10%) treated with 6 mg and no subjects (0%) treated with 3 mg SC sumatriptan.

Conclusions

DFN-11 provided relief of migraine pain, associated symptoms and tolerability similar to a 6 mg SC sumatriptan. The 3 mg dose showed a numerical advantage in duration of triptan sensations that requires confirmation in a fully-powered study. DFN-11 may be a useful option for the acute treatment of migraine.

Authors/Disclosures
Roger Cady, MD (RK Consulting, LLC) PRESENTER	Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.
	No disclosure on file
Ryan J. Cady (Clinvest Research)	No disclosure on file
	No disclosure on file
	No disclosure on file

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