New Study Confirms Long-Term Safety And Tolerability Of ZOMIG® (zolmitriptan) Nasal Spray For Treatment Of Migraine

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 are consistent over study duration, according to results of a new study examining the medication 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.[i]

"The long-term use and safety record of prescription medications should always be a consideration for physicians when treating patients with recurring conditions such as migraine headache," said Andrew J. Dowson, MD, Director, King's Headache Service, King's College Hospital, London. "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, noncomparative, multicenter phase III trial that assessed the long-term safety and tolerability of ZOMIG Nasal Spray 5 mg 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 serious adverse events were considered to be drug-related (nausea, vertigo and angina pectoris). The only adverse events to occur in ≥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.

The incidence of adverse events declined over time (43.4% of attacks from 0-90 days; 30.8% from 91-180 days; 28.7% from 181-270 days; 27.1% from 271-360 days; 30.7% at 361 days or later), despite the very low withdrawal rates due to adverse events (4.5% of patients). The incidence of recorded nasopharyngeal events also declined during the study (21.8% of attacks at 0-90 days; 12.8% at 91-180 days; 11.5% at 181-270 days; 11.4% at 271-360 days; 12.2% at 361 days or later). These results suggest that patients who had not previously used a triptan nasal spray soon became familiar with the characteristic sensations of nasal dosing and therefore stopped reporting such sensations as adverse events.

Data from the INDEX study also confirm the efficacy of ZOMIG Nasal Spray. In 20,717 attacks treated, more than half (53.8%) were recorded as pain-free two hours after initial treatment, despite most being treated at moderate or severe baseline intensity. These results were consistent over study duration, with overall two-hour pain-free rates ranging from 51.2% to 55.8%.