FDAnews
www.fdanews.com/articles/86646-vernalis-endo-report-frova-data

VERNALIS, ENDO REPORT FROVA DATA

May 8, 2006

Vernalis and Endo Pharmaceuticals have announced top-line data from the second Phase III efficacy study of Frova 2.5 mg tablets for the short-term prevention of menstrual migraine. Early data from a clinical trial showed that Frova reduced the frequency of menstrual migraine.

In a late-stage clinical trial, 427 women were given either Frova or a placebo for three months to treat migraines that occurred around their periods. The study found that Frova significantly increased the number of total periods that were free of migraine compared with the placebo.