Long‐term Efficacy of Subcutaneous Sumatriptan Using a Novel Self‐injector

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Abstract
An open, multicenter study investigated the long‐term efficacy, tolerability, and acceptability to patients of subcutaneous sumatriptan 6 mg, administered using a novel cartridge system self‐injector, for the acute treatment of migraine. Eighty patients treated all migraine attacks for 6 months at home with a subcutaneous injection of sumatriptan 6 mg. A second injection could be taken after 1 to 24 hours if relief was inadequate, or if the headache recurred, and rescue medication could be taken 1 hour after the second injection. The primary end point was the percentage of attacks in which headache improved from severe or moderate before treatment to mild or absent at 1 hour after the first injection. A total of 1566 attacks were treated by the 80 patients and 69 patients completed 6 months of treatment. Headache relief was reported 1 hour after the first injection in a mean of 78% of attacks (83% in the first 3 months and 76% in the second 3 months). A second injection was required in a mean of 40% of attacks, and headache was mild or absent 1 hour after the second injection in a mean of 77% of attacks. Rescue medication was required after the second injection in a mean of 14% of attacks. At the end of the study, 87% of patients said that they would take the medication again, and at each clinic visit over 80% said that they found the injector easy to use. Adverse events were similar to those reported previously with sumatriptan and were mostly mild to moderate in intensity, short‐lived, and resolved spontaneously.Subcutaneous sumatriptan 6 mg is an effective, well tolerated, and well accepted, long‐term, acute treatment for migraine when self‐injected by patients using the novel self‐injector.

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