Drug for Migraine Prevention near Approval

By Jancin, Bruce | Clinical Psychiatry News, June 2004 | Go to article overview

Drug for Migraine Prevention near Approval


Jancin, Bruce, Clinical Psychiatry News


SAN FRANCISCO -- Anticipating the imminent marketing approval of topiramate for prevention of migraine, investigators presented a flood of supportive data at the annual meeting of the American Academy of Neurology.

Ortho-McNeil Pharmaceutical has already received a letter from the Food and Drug Administration declaring the neuromodulatory drug "approvable" for migraine prevention in adults. Final marketing approval is anticipated this summer after the exact labeling language is worked out.

The recommended target dose will be 50 mg b.i.d. In clinical trials, that has been roughly as effective as 100 mg b.i.d., but with 25% fewer adverse events, said Dr. Fred Freitag of the Diamond Headache Clinic, Chicago.

Dr. Freitag is a consultant to Johnson & Johnson, the parent company of Ortho-McNeil.

Studies presented at the meeting provided a new and more detailed picture of topiramate's safety profile in migraine prophylaxis and also showed for the first time that daily use of the preventive medication enhances the efficacy of triptans in patients previously resistant to that important form of acute abortive therapy. Even though topiramate will receive FDA approval for migraine prevention only in adults, preliminary data were presented showing notable benefits in adolescents as well.

In 26-week randomized efficacy trials totaling nearly 1,000 migraineurs, 100 mg/day of topiramate resulted in at least a 50% reduction in migraine frequency in 52% of treated patients, compared with 23% of those on placebo. Of patients on topiramate, 27% experienced at least a 75% decrease in migraine frequency. Dr. Freitag presented a post hoc analysis of the pooled data showing that onset of response occurred early, with a significant difference in weekly migraine frequency between the topiramate and placebo arms becoming evident at week 1.

Dr. James Adelman presented a safety assessment of topiramate based upon four randomized double-blind placebo-controlled clinical trials involving 1,580 migraine patients. Most adverse events were mild to moderate in severity. Paresthesias were the most common adverse event, affecting 51% of patients on topiramate at 100 mg/day.

One-quarter of patients on 100 mg/day withdrew from the study due to adverse events, as did 10% of those on placebo. Most topiramate withdrawals occurred within the first month. Of treated patients, 7% discontinued topiramate because of paresthesias, 4% due to nausea, 4% due to fatigue, 3% due to insomnia, and another 3% due to difficulty in concentrating.

A side effect of topiramate that most patients will welcome was the dose-related weight loss. …

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