Randomized, double-blind, crossover study comparing DFN-11 injection (3 mg subcutaneous sumatriptan) with 6 mg subcutaneous sumatriptan for the treatment of rapidly-escalating attacks of episodic migraine

• Published in: Journal of headache and pain Vol. 18; no. 1; pp. 17 - 8
• Main Authors: Cady, Roger K., Munjal, Sagar, Cady, Ryan J., Manley, Heather R., Brand-Schieber, Elimor
• Format: Journal Article
• Language: English
• Published: Milan Springer Milan 01.12.2017; Springer Nature B.V
• Subjects: Adult; Cross-Over Studies; Double-Blind Method; Female; Health care; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Migraine; Migraine Disorders - drug therapy; Neurology; Outcome Assessment (Health Care); Pain Medicine; Pilot Projects; Research Article; Serotonin 5-HT1 Receptor Agonists - administration & dosage; Serotonin 5-HT1 Receptor Agonists - adverse effects; Serotonin 5-HT1 Receptor Agonists - pharmacology; Studies; Sumatriptan - administration & dosage; Sumatriptan - adverse effects; Sumatriptan - pharmacology; Young Adult; Treatment; Episodic; Sumatriptan; Subcutaneous; Migraine; Rapidly-escalating
• ISSN: 1129-2369; 1129-2377; 1129-2377
• DOI: 10.1186/s10194-016-0717-7

Background A 6-mg dose of SC sumatriptan is the most efficacious and fast-acting acute treatment for migraine, but a 3-mg dose of SC sumatriptan may improve tolerability while maintaining efficacy. Methods This randomized, double-blind, crossover study compared the efficacy and tolerability of 3 mg subcutaneous (SC) sumatriptan (DFN-11) with 6 mg SC sumatriptan in 20 adults with rapidly-escalating migraine attacks. Eligible subjects were randomized (1:1) to treat 1 attack with DFN-11 and matching placebo autoinjector consecutively or 2 DFN-11 autoinjectors consecutively and a second attack similarly but with the alternative dose (3 mg or 6 mg). Results The proportions of subjects who were pain-free at 60 min postdose, the primary endpoint, were similar following treatment with 3 mg SC sumatriptan and 6 mg SC sumatriptan (50% vs 52.6%, P   =  .87). The proportions of subjects experiencing pain relief ( P   ≥  .48); reductions in migraine pain intensity ( P   ≥  .78); and relief from nausea, photophobia, or phonophobia ( P   ≥  .88) with 3 mg SC sumatriptan and 6 mg SC sumatriptan were similar, as were the mean scores for satisfaction with treatment ( M   =  2.6 vs M   =  2.4, P   =  .81) and the mean number of rescue medications used ( M   =  .11 vs M   =  .26, P   =  .32). The most common adverse events with the 3- and 6-mg doses were triptan sensations — paresthesia, neck pain, flushing, and involuntary muscle contractions of the neck — and the incidence of adverse events with both doses was similar (32 events total: 3 mg, n   =  14 [44%]; 6 mg, n   =  18 [56%], P   =  .60). Triptan sensations affected 4 subjects with the 6-mg dose only, 1 subject with the 3-mg dose only, and 7 subjects with both sumatriptan doses. Chest pain affected 2 subjects (10%) treated with the 6-mg dose and no subjects (0%) treated with the 3-mg dose of DFN-11. There were no serious adverse events. Conclusions The 3-mg SC dose of sumatriptan in DFN-11 provided relief of migraine pain and associated symptoms comparable to a 6-mg SC dose of sumatriptan. Tolerability was similar with both study medications; DFN-11 treatment was associated with fewer triptan sensations than the 6-mg dose. DFN-11, with its 3-mg dose of sumatriptan, may be a clinically useful alternative to higher-dose autoinjectors.