She presented two large sponsored clinical trials of zolmitriptan nasal spray. One was a double-blind, dose-finding study in which 1,371 patients were randomized to the 2.5mg oral zolmitriptan tablet, placebo, or to the nasal spray at doses of 0.5,1, 2.5, or 5 mg. The assigned medication was used to treat three migraine attacks of moderate to severe intensity. All doses of spray beat placebo, but only the 2.5-mg tablet. The primary study end point-headache response at 2 hours–was achieved by 30 percent of patients on placebo, 61 percent on the tablet, and 70 percent on the 5-mg spray.
As early as 15 minutes post treatment, the 5-mg spray had a significantly higher pain-free response rate than the standard tablet. In a post hoc analysis, 2-hour response rates to the spray and tablet were similar in patients without nausea and vomiting. In those who headaches were accompanied by these GI symptoms, however, the 2-hour response rate was 68 percent with the nasal spray, compared with 57 percent with the tablet. Forty-seven percent of patients using the 5-mg nasal spray reported that all three treated headaches responded, as did 42 percent on the Zomitriptan tablet and nine percent on placebo.
In a year-long study of 783 migraineurs who used the 5-mg nasal spray, the product’s efficacy remained consistent over time, with 2-hour response rates of 73 percent to 75 percent in each quarter. Side effects followed the usual triptan pattern and, like efficacy, remained consistent over time, with mild adverse events noted in roughly 22 percent of treated attacks over the course of a year. Reviewing the topic of headache at the meeting’s annual scientific highlights summary, called zolmitriptan nasal spray, with its promise of early effectiveness, the key recent therapeutic development in the field. But posed a question: Given the strong dose-response curve evident in the dose-finding study, why not go higher that 5 mg?
If one had tried 7.5 mg or higher, she would have gotten an even better response, maybe as observed by a director of the Houston Headache Clinic, considering a study of a 10-mg spray. In other news of investigational migraine agents, one doctor reported on a pivotal multicenter, double-blind trial in which 1,334 migraineurs were randomized to 20,40, or 80 mg of oral eletriptan or placebo for treatment of three migraine attacks. All three doses of the investigational triptan proved more effective than placebo. All three headaches responded to 20 mg of eletriptan in 32 percent of cases, the 40 mg in 47 percent and to 80 mg in 60 percent, compared with eight percent with placebo in the Pfizer Inc. – sponsored trial.
Think of 60 percent response rate to three out of three is pretty impressive commented on doctor of New England Center for Headache, Stamford, Connecticut. The Food and Drug Administration has issued a letter calling eletriptan "approvable", but wants to see more data on the cardiovascular safety of the 80-mg dose.