Part II: Clinical efficacy and tolerability of zolmitriptan orally disintegrating tablet in the acute treatment of migraine

Abstract

ABSTRACTControlled clinical trials and extensive clinical use of conventional oral tablets of zolmitriptan, a selective agonist of serotonin1B/1D receptors, have proven the compound to be fast-acting, highly effective, and well-tolerated in the acute treatment of migraine. An orally disintegrating tablet (ODT) of zolmitriptan that dissolves on the tongue without the need for fluid intake has been developed in order to provide an acceptable, convenient alternative for patients who prefer not to, or cannot, take conventional tablets. A fast onset of effective, sustained pain relief was predicted for zolmitriptan ODT on the basis of its bioequivalence with the conventional tablet, which has been confirmed in three randomised, double-blind, placebo-controlled trials of zolmitriptan ODT in the acute treatment of migraine. Compared with placebo, significantly higher proportions of patients treated with zolmitriptan ODT responded to treatment (reduction of moderate or severe headache to mild or no pain) as early as 30 minutes after dosing. Headache response was maintained at 24 hours in significantly higher proportions of patients receiving zolmitriptan ODT compared with placebo. Zolmitriptan ODT also resulted in significantly greater pain-free rates than placebo as early as 1 hour after dosing. Zolmitriptan ODT relieved patients of other migraine-associated symptoms, including nausea, photophobia and phonophobia, and enabled >50% of patients to resume normal daily activities 2 hours after dosing. Adverse events observed with zolmitriptan ODT were similar to those associated with the serotonin1B/1D agonists as a class, and were generally transient and of mild or moderate intensity.