FDAnews
www.fdanews.com/articles/83279-vernalis-completes-frovatriptan-study

VERNALIS COMPLETES FROVATRIPTAN STUDY

December 20, 2005

Vernalis has announced the successful completion of a long-term Phase III open-label safety study of frovatriptan administered for six days a month for 12 months in the prevention of migraine in patients with migraines related to their menstrual cycles.

In total, 525 patients entered the study and 308 completed all 12 treatment cycles with over 4,000 perimenstrual periods treated during the study.

The treatment regimen for frovatriptan in this study involved 5 mg of the drug twice daily on the first day, followed by 2.5 mg twice daily for the remaining five days. Patients were instructed to begin treatment two days before their anticipated day of migraine headache.