Treatment of Acute Migraine with Zolmitriptan Nasal Spray
Zolmitriptan is a selective serotonin receptor agonist of 1B and 1D subtypes. It is a triptan used in the acute treatment of migraine attacks with or without aura and cluster headaches. Zolmitriptan is available as a swallowable tablet, an oral disintegrating tablet and a nasal spray. It has been reported that nasal spray showed positive results on the patients with migraine. To assess the efficacy and tolerability of zolmitriptan nasal spray for treating acute migraine in adolescents, TEENZ study was conducted.
A randomized, double-blind, placebo-controlled, four-arm parallel-group conducted study included patients who completed a 30 day run in period to treat a single migraine attack with single-blind placebo nasal spray. Eligible patients, who had not responded to placebo, were randomized to one of three zolmitriptan nasal spray doses or placebo in a ratio of 5:3:3:5 according to a computer-generated randomization scheme. Patients completed diaries for 24 hours after treatment headache pain scores, adverse events (AEs) and medications taken.
After the analyses of an interim futility analyses, zolmitriptan nasal spray doses of 0.5 and 2.5mg were declared futile relative to placebo and further randomization to those treatment arms were discontinued. Of 1653 patients enrolled into the study, 855 patients could not meet eligibility criteria and were considered as screen failures. Of 796 patients who were randomized to treat, 721 (90.4%) completed the study period. Of these 657 (82.3%) treated a migraine within the study period and contributed data for analyses. Zolmitriptan nasal spray 5mg was significantly more effective than placebo in achieving pain free status at 2 hours after treatment with 30% patients achieving pain free status at 2 hours vs 17% of placebo treated patients. It was also more effective than placebo in achieving pain free status at 3 and 4 hours post-treatment and headache response at 2, 3 and 4 hours after treatment.
Zolmitriptan nasal spray was well tolerated at all doses. Dysgeusia was the most frequently reported AE with greater frequencies. There were no other serious AEs leading to discontinuation. Hence, Zolmitriptan 5mg nasal spray has been demonstrated to be of superior efficacy and safety compared with placebo.