Zolmitriptan Orally Disintegrating Tablet is Effective in the Acute Treatment of Migraine

Abstract

A new formulation of zolmitriptan has been developed that dissolves on the tongue without the need for additional fluid intake. In this double-blind, parallel study, 471 patients were randomized to receive the zolmitriptan orally disintegrating tablet 2.5 mg (n=231) or matching placebo (n=240) to treat a single moderate or severe migraine. Headache relief following zolmitriptan 2.5 mg (63%) was significantly greater than with placebo (22%) at 2 h post-dose (primary endpoint; P < 0.0001). The zolmitriptan orally disintegrating tablet was also significantly more effective than placebo for 1-, 2- and 4-h pain-free response (8% vs. 3%, P=0.0207, 27% vs. 7%, P< 0.0001, and 37% vs. 11%, P < 0.0001, respectively). Of those patients stating a preference, 70% of patients preferred the orally disintegrating tablet to a conventional tablet. Zolmitriptan orally disintegrating tablets are an effective and convenient alternative to a conventional tablet, allowing migraine attacks to be treated anytime a migraine strikes, which can facilitate earlier treatment.

A Review of the Pharmacokinetics, Pharmacodynamics and Efficacy of Zolmitriptan in the Acute Abortive Treatment of Migraine

“…75 Zolmitriptan orally disintegrating tablet (ODT) has been shown to have superior effi cacy against placebo in three double-blind, placebo controlled trials in the treatment of acute migraine. [72][73][74] Zolmitriptan 2.5 mg and 5 mg ODT showed a 63% and 59% 2 hour headache response rate as compared to 22% and 31% for placebo. The 2 hour pain free rate was 27%-47% and 31% for zolmitriptan 2.5 mg and zolmitriptan 5 mg ODT respectively versus 7%-20% and 11% for placebo.…”

“…The mean 24 hour sustained pain free response for the 2.5 mg ODT is 29% (versus11% for placebo) and for the 5 mg ODT was 43% (versus 16% for placebo). [72][73][74] As with the tablet formulations, zolmitriptan nasal spray has been shown in several studies to be signifi cantly more effective for pain relief at 2 hours as compared to placebo for acute migraine therapy. 58,77,78 In the fi rst of these studies, the 2 hour headache response rate for the 2.5 mg and 5 mg nasal spray doses, were 59% and 70% respectively, as compared to 31% for placebo; and the headache response was signifi cantly greater for both doses as compared to placebo as early as 15 minutes.…”

“…The withdrawal rate because of adverse events in this study was very low (3.4%) and similar to that seen in controlled studies of zolmitriptan ODT. 73,98 Patient preference was also evaluated in an open post marketing surveillance study of 12,919 patients, treating 36,510 migraine attacks with zolmitriptan 2.5 mg Compared with all previous therapies like herbal remedies, homeopathic, magnesium and analgesics, 85% of patients preferred zolmitriptan on effi cacy grounds, while 56% considered it to be better tolerated. 111 Second, in a study evaluating only taste preference, patients received either the ODT of either zolmitriptan or rizatriptan to assess the fl avor and after-taste.…”

Effectiveness and medication acceptance of olanzapine disintegrating tablets compared to standard olanzapine tablets in acutely treated psychiatric patients

“…Removal of ODT from the tongue is also more diffi cult than for the standard (coated) olanzapine tablet (SOT) since it forms an amorphous residue that can only be removed by scraping the tongue. The use of orally disintegrating tablets in other indications (eg, migraine, depression), has been successfully tested in other studies (Dowson et al 2002;Behnke et al 2003). Improved compliance has, besides improved cognitive functioning and reduced negative symptoms, also been identifi ed as a possible factor leading to a decrease in suicidality (Meltzer et al 1998).…”

Zolmitriptan nasal spray provides fast relief of migraine symptoms and is preferred by patients: a Swedish study of preference in clinical practice

“…An orally disintegrating tablet formulation, which does not require additional fluid intake, has also been available since the late 1990s. The convenience of this formulation may facilitate earlier intervention [12], an approach that has been shown to result in a better response to therapy among migraine patients in recent studies [13,14]. Despite this, an oral formulation may not be suitable for the treatment of all migraine attacks, particularly those associated with nausea and vomiting.…”