SUMATRIPTAN NASAL SPRAY FOR THE ACUTE TREATMENT OF MIGRAINE - RESULTSOF 2 CLINICAL-STUDIES

Background: Sumatriptan nasal spray may be particularly useful for pat ients whose nausea and vomiting preclude them from using oral migraine medication or for patients who prefer not to use an injectable migrai ne medication. The objective of this study was to evaluate in two clin ical studies the efficacy and tolerability of the intranasal form of s umatriptan in the acute treatment of a single migraine attack. Interna tional Headache Society-diagnosed adult migraineurs in two randomized, double-blind, parallel-group, multicenter studies (n = 409 and 436) u sed sumatriptan nasal spray 20 mg, 10 mg, or placebo (2:1:1) for the a cute treatment of a single migraine attack at home. Predose and at pre determined postdose intervals, patients recorded headache severity (no ne, mild, moderate, severe); time to meaningful relief; clinical disab ility (none, mildly impaired, severely impaired, bed rest required); p resence/absence of nausea, photophobia, and phonophobia; and the occur rence of adverse events. Two hours postdose in the two studies, modera te or severe baseline pain was reduced to mild or none in 62 to 63% of patients treated with sumatriptan 20 mg, 43 to 54% of patients treate d with sumatriptan 10 mg, and 29 to 35% of placebo-treated patients (p < 0.05 20 mg versus placebo for both studies and 10 mg versus placebo for study 1). Onset of relief relative to placebo began as early as 1 5 minutes postdose (sumatriptan 20 mg, study 2). Clinical disability a t 2 hours postdose was reported as mildly impaired or normal in 72 to 74% of patients treated with sumatriptan 20 mg, 56 to 68% of patients treated with sumatriptan 10 mg, and 47 to 58% of placebo-treated patie nts (p < 0.05 20 mg versus placebo for both studies). Similar efficacy rates were observed for nausea, photophobia, and phonophobia. The mos t common adverse event in the active treatment groups was disturbance of taste (bad, bitter, or unpleasant taste). Aside from this event, th e pattern and incidence of adverse events did not differ among treatme nt groups. From these results we determined that sumatriptan nasal spr ay is a rapidly effective, well-tolerated migraine treatment. The 20-m g dose was effective in treating the entire migraine symptom complex, and the 10-mg dose was less consistently effective.