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Rapid oral transmucosal absorption of sumatriptan, and pharmacodynamics in acute migraine
Headache: The Journal of Head and Face Pain, 06/25/09

Dilone E et al. – The initial pharmacokinetics of lingual spray (LS) approximate to those of subcutaneous injection, despite some fraction of swallowed dose. These pharmacokinetics correspond with earlier effectiveness of LS compared with a 50-mg sumatriptan tablet, and at lower dose, in an enriched, relevant pt population.

Methods

Study of whether sumatriptan is absorbed across oral mucosa
Description of pharmacokinetics
Evaluation of potential pharmacodynamic correlates of such pharmacokinetics in pts with migraine attacks
Clinical trial 1: comparison of pharmacokinetic performance of sumatriptan LS formulation (2 dose sizes, 1 in both fed/fasted state) vs orthodox 50-mg sumatriptan tablet in normal volunteers
Clinical trial 2: multiple-attack, crossover, fixed dose-order, open-label comparison of sumatriptan LS (up to 3 different dose sizes) vs 100-mg sumatriptan tablet for pt population enriched by documenting suboptimal response to initial 50-mg sumatriptan tablet

Results

LS formulations resulted in double-peaked time-plasma concentration curves consistent with absorption of sumatriptan across oral mucosa
First Tmax usually ~10-15 min
In enriched pt population, first Tmax corresponded with evidence of earlier efficacy for LS vs 50-mg tablet
Lower dose size for former consistent with oral mucosal drug absorption and evasion of first-pass metabolism

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