The trial, named INDEX, was an open-label multi-center phase III trial that assessed the long-term safety and tolerability of Zomig (zolmitriptan) nasal spray 5mg in 538 adult patients who treated 20,717 migraine attacks during one year.
Serious adverse events were very rare, and only three serious adverse events were considered to be drug- related. The only adverse events to occur in greater than or equal to 4% of attacks were unusual taste and paresthesia, but these led to treatment withdrawal in only 0.4% and 0.6% of patients, respectively.
The incidence of adverse events declined over time, despite the very low withdrawal rates due to adverse events. The incidence of recorded nasopharyngeal events also declined during the study. 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 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%.
“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,” said Dr Andrew Dowson, director of King’s Headache Service at King’s College Hospital, London. “These data should be of particular value to physicians in the ongoing treatment of their migraine headache patients.”
Zomig is marketed and sold by MedPointe Pharmaceuticals in the US, in accordance with a marketing distributorship with AstraZeneca.