| Abstract: | SUMMARYBackground: A new oral form of sumatriptan has been developed to facilitate tablet disintegration and drug dispersion and to mitigate the effects of gastric stasis that can accompany migraine.Objective: To evaluate the effects on functional ability of the new fast disintegrating/rapid release formulation of sumatriptan.Methods: Sumatriptan 50?mg (n = 137), 100?mg (n = 142), or placebo (n = 153) was administered early when pain was mild for the acute treatment of a single migraine attack in a randomized, double-blind, parallel-group, placebo-controlled clinical trial. For this report, main health-outcomes endpoints (which were secondary endpoints for this clinical trial that was primarily designed to assess pain-free efficacy) included functional ability measured through 2?h postdose on a 5-point scale and lost time equivalents, a composite measure of migraine-associated time missed from activities, and reduced effectiveness at activities through 24?h postdose.Results: Normal functional ability was restored in a significantly (?p < 0.05) greater percentage of patients treated with sumatriptan than placebo beginning 45?min postdose for sumatriptan 100?mg and 1?h postdose for sumatriptan 50?mg. During the 24?h after initial dosing, the median (range) lost time equivalents for the combination of paid work activities and activities outside of paid work were significantly lower in the groups treated with sumatriptan (1.1 0–10] sumatriptan 100?mg; 0.8 0–36] sumatriptan 50?mg) compared with placebo (2.9 0–24]) (?p ≤ 0.01 each sumatriptan group versus placebo). The corresponding mean ± SD values for lost time equivalents were 1.9 ± 2.3 and 2.5 ± 4.7 for sumatriptan 100?mg and 50?mg, respectively, compared with 3.5 ± 4.3 for placebo.Conclusion: A new oral sumatriptan formulation confers rapid, sustained restoration of functional ability in the acute treatment of migraine so that patients can return rapidly to normal functioning at work and outside of work. |
