Objective: This double-blind, parallel, multicentre study investigated the
effect of migraine on absorption of oral sumatriptan (25, 50 and 100mg) com
pared with placebo.
Design: Patients received sumatriptan or placebo in the clinic during an ac
ute migraine and at least 7 days later, when pain-free. Pharmacokinetic and
efficacy (n = 192) and safety (n = 259) parameters were assessed for 4 hou
rs after administration of study medication.
Results: Absorption of sumatriptan from 50 and 100mg tablets was not signif
icantly different between the migraine and pain-free periods. There was how
ever a statistically significant decrease (approximately 23%) and delay (35
minutes) in absorption of sumatriptan from the 25mg tablet during a migrai
ne compared with the pain-free period. Sumatriptan pharmacokinetics exhibit
ed dose proportionality during the migraine and pain-free periods. All dose
s of sumatriptan were significantly superior to placebo in reducing headach
e pain. Adverse events were comparable among the sumatriptan groups and pla
cebo group.
Conclusions: Absorption of sumatriptan, administered at therapeutic doses,
was not statistically significantly impaired during migraine versus the pai
n-free state. These data suggest that coadministration of drugs that improv
e the absorption of sumatriptan is not necessary during sumatriptan treatme
nt.