Controlled 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.