PHILADELPHIA—An iontophoretic transdermal delivery of sumatriptan provided statistically significant improvement compared with placebo for rapid, consistent, and sustained relief of acute migraine headache, according to research presented at the 14th Congress of the International Headache Society. For patients who experience nausea and cannot tolerate oral sumatriptan, the migraine patch may be especially beneficial, reported Jerome Goldstein, MD, of the San Francisco Clinical Research Center, and colleagues.
In a randomized, double-blind, placebo-controlled phase III clinical trial, 530 patients with a history of migraine were randomly assigned to receive either the migraine patch (Zelrix; NuPathe Inc, Conshohocken, PA), which delivered sumatriptan during a four-hour period, or an identical looking placebo patch that delivered sodium in place of the medication. At migraine onset, patients were instructed to rate their baseline headaches on a four-point scale and apply the study patch only if their score was two or three. Patients were not permitted to take any analgesic or antiemetic medication during the eight hours before or two hours following patch activation. Subjects remained in the study until one migraine was treated with the study patch or two months had passed following randomization, whichever occurred first. At the end of the study, 61 patients did not experience a migraine in the two-month period and were eliminated from the results, which left 226 patients in the migraine patch group (mean age, 40.7; 84% women) and 228 patients in the placebo group (mean age, 41.0; 86% women).
Two hours after patch activation, a significantly higher proportion of patients who received the migraine patch were headache pain-free compared with placebo (19% vs 9%, respectively), and this “significant difference from placebo continued for all subsequent time points up to and including 12 hours after patch activation,” Dr. Goldstein’s group reported. “The migraine patch was also associated with a significantly higher proportion of patients reporting headache pain relief as early as one hour following patch activation compared with placebo (29% vs 19%, respectively).”
In addition, a greater proportion of patients who received the treatment were nausea-free within one hour after patch application compared with the placebo group (71% vs 58%, respectively), and the difference was maintained for up to 12 hours. Within two hours, a greater proportion of migraine patch patients than placebo subjects were photophobia-free (51% vs 36%, respectively) and phonophobia-free (55% vs 39%, respectively), and this difference was also maintained for up to 12 hours.
A greater number of patients who received the medication compared with placebo reported or experienced sustained pain relief from two hours through 24 hours after patch activation (34% vs 21%, respectively), being migraine free two hours after patch activation (16% vs 8%, respectively), and no use of rescue medication (60% vs 40%, respectively). Fifty-one percent of migraine patch patients and 45% of those who received placebo reported adverse events. The most commonly reported side-effects were pain, itching, and rashes at the application site, and were similar to placebo.
—Rebecca K. Abma