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.
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.
Clinvest/A Division of Banyan Inc., 3805 S Kansas Expy, Springfield, MO, 65807, USA.
Roger K
RK
Cady
Dr. Reddy's Laboratories Ltd., 107 College Road East, Princeton, NJ, 08540, USA.
Sagar
S
Munjal
Clinvest/A Division of Banyan Inc., 3805 S Kansas Expy, Springfield, MO, 65807, USA. ryancady@clinvest.com.
Ryan J
RJ
Cady
Clinvest/A Division of Banyan Inc., 3805 S Kansas Expy, Springfield, MO, 65807, USA.
Heather R
HR
Manley
Dr. Reddy's Laboratories Ltd., 107 College Road East, Princeton, NJ, 08540, USA.
Elimor
E
Brand-Schieber
D000328:Adult; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D010865:Pilot Projects; D058825:Serotonin 5-HT1 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D018170:Sumatriptan / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D055815:Young Adult
D058825:Serotonin 5-HT1 Receptor Agonists; D018170:Sumatriptan
Episodic; Migraine; Rapidly-escalating; Subcutaneous; Sumatriptan; Treatment