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 (P1.10-007)

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. Disclosure: Dr. Cady has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Alder BioPharmaceuticals, Inc. Dr. Munjal has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr Reddy & Laboratories. Dr. Cady has nothing to disclose. Dr. Manley has nothing to disclose. Dr. Brand-Schieber has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr. Reddy’s Laboratories.