New study confirms Zomig long-term safety

AstraZeneca's Zomig (zolmitriptan) nasal spray is well-tolerated for the treatment of migraine during long-term use of up to one year, and its efficacy and tolerability were consistent over the study's duration, according to results of a new clinical trial examining the product in the treatment of more than 20,000 migraine attacks. Results of the INDEX trial were published in the January issue of Headache, the official journal of the American Headache Society.

Andrew Dowson, director of the King's Headache Service at King's College Hospital, London, UK, said: "the results of this study confirm that Zomig nasal Spray, when used repeatedly by migraine sufferers over a one-year period, was well-tolerated and highly effective in providing relief from headache pain. These data should be of particular value to physicians in the ongoing treatment of their migraine headache patients."

INDEX was an open-label, non-comparative, multicenter Phase III trial that assessed the long-term safety and tolerability of Zomig nasal spray 5mg in 538 adult patients who treated 20,717 migraine attacks of any baseline severity during one year. Serious adverse events were very rare (0.1% of attacks), and only three SAEs were considered to be drug-related (nausea, vertigo and angina pectoris). The only AE to occur in greater than or equal to 4% of attacks were unusual taste (19.0%) and paresthesia (6.8%), but these led to treatment withdrawal in only 0.4% and 0.6% of patients, respectively, it was noted.