MULTIPLE-ATTACK EFFICACY AND TOLERABILITY OF SUMATRIPTAN NASAL SPRAY IN THE TREATMENT OF MIGRAINE

Objective: Sumatriptan hemisulfate nasal spray may provide a useful th erapeutic option for patients with migraine who find injectable medica tions inconvenient or uncomfortable and for patients whose migraine-as sociated nausea and vomiting preclude the use of oral medication. This study was the first US trial to evaluate the effects of sumatriptan n asal spray administered for multiple migraine attacks. Design/Interven tions: Sumatriptan nasal spray (5, 10, or 20 mg) was administered via a 1-shot nasal applicator into either nostril for up to 3 migraine att acks occurring over 6 months in a randomized, double-blind, parallel-g roup, placebo-controlled study. Setting: Fifty-six outpatient clinical centers in the United States. Patients: A total of 1086 men and women diagnosed with migraine with or without aura per International Headac he Society criteria. Main Outcome Measures: Percentage of patients wit h headache relief (moderate or severe predose gain reduced to mild or none); percentage of patients with no or mild (vs moderate or severe) clinical disability; percentage of patients with nausea, vomiting, pho tophobia, or phonophobia; adverse events; clinical laboratory test res ults. Results: Across attacks, headache relief in the 20-, 10-, and 5- mg drug and placebo groups was experienced 120 minutes postdose by 60% , 54%, 44%, and 32% of patients, respectively (P<.05 for each sumatrip tan nasal spray group vs placebo, for the 10-mg vs 5-mg drug group, an d for the 20-mg vs 5-mg drug group). Two thirds of the 20-mg patients treating 3 attacks experienced relief at 2 hours postdose for at least 2 of 3 attacks. Clinical disability scores at 120 minutes in the 20-, 10-, and 5-mg drug and placebo groups reflected no or mild impairment in 70%, 67%, 57%, and 50% of patients, respectively (P<.05 for the 10 - or 20-mg drug group vs placebo group, and for the 20-mg vs 5- mg dru g group). Similar efficacy rates were observed for nausea, photophobia , and phonophobia. For all parameters, individual-attack efficacy rate s did not differ from across-attack rates. The incidence of adverse ev ents was not dose related. The most frequently reported adverse event in the active treatment groups was taste disturbance (bad, bitter, or unpleasant). Conclusions: Sumatriptan hemisulfate nasal spray (5, 10, or 20 mg) is effective and well tolerated in the treatment of multiple migraine attacks. The 20-mg dose was associated with the highest effi cacy rates across the greatest number of parameters.