Sumatriptan fast-disintegrating/rapid-release tablets.
Sumatriptan is a serotonin 5-HT(1B/1D) receptor agonist that is used for the acute treatment of migraine attacks. A new fast-disintegrating/rapid-release sumatriptan tablet (sumatriptan FDT/RRT) has been developed with the goal of speeding absorption and onset of effect compared with standard sumatriptan tablets. Bioequivalence of sumatriptan FDT/RRT tablets to standard sumatriptan tablets was established in healthy volunteers. Initial data suggest that sumatriptan FDT/RRT tablets may disintegrate faster and get emptied from the stomach faster than standard sumatriptan tablets. In a randomised, double-blind, multicentre, early intervention trial in adults with mild migraine, significantly more sumatriptan FDT/RRT 50 and 100mg recipients than placebo recipients were pain free or migraine free 2 hours after receiving study medication. Compared with placebo, pain relief was significantly greater with sumatriptan FDT/RRT 100mg at 25 and 17 minutes following administration, and with sumatriptan FDT/RRT 50mg at 50 and 30 minutes following administration, in two randomised, double-blind, multicentre trials in adults with moderate to severe migraine. Sumatriptan FDT/RRT tablets were generally well tolerated; the tolerability profile was similar to that reported for standard sumatriptan tablets in other studies.
Moen
Marit D
MD
Adis International Limited, 41 Centorian Drive, Mairangi Bay, Auckland 1311, New Zealand. demail@adis.co.nz
Keating
Gillian M
GM
D000328:Adult; D019540:Area Under Curve; D017326:Clinical Trials, Phase III as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000188:drug therapy*; D016032:Randomized Controlled Trials as Topic; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D018170:Sumatriptan / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D013607:Tablets; D016896:Treatment Outcome
D017366:Serotonin Receptor Agonists; D013607:Tablets; D018170:Sumatriptan