Vernalis, Endo: Frova meets primary endpoint in second phase 3 study to prevent menstrual migraine

By E. Janene Geiss

Philadelphia, May 8 - Vernalis plc and Endo Pharmaceuticals Holdings Inc. announced Monday top-line data from the second phase 3 efficacy study of Frova (frovatriptan succinate) 2.5 mg tablets for the short-term (six-days per month) prevention of menstrual migraine.

The data from this study corroborate the positive findings in a prior efficacy study published in Neurology in July 2004, according to a company news release.

Endo said it expects to file a supplemental New Drug Application with the Food and Drug Administration in the coming weeks to seek approval for the additional indication of Frova for the prevention of menstrual migraine.

If approved, Frova will be the only triptan indicated in the United States for the prevention of menstrual migraine.

Frova is FDA-approved for the acute treatment of migraine attacks with or without aura in adults where a clear diagnosis of migraine has been established.

"Menstrual migraines can have significant impact on a woman's life. The preliminary results of this study are encouraging for women who suffer from menstrual migraine and who have not responded well to acute treatment," said the lead investigator in the trial, Jan Lewis Brandes of the Nashville Neuroscience Group and of the Department of Neurology at Vanderbilt University School of Medicine.

Patients in the study were treated for three peri-menstrual periods, and the primary endpoint was the number of menstrual migraine-free peri-menstrual periods. Both once- and twice-daily dose regimens of Frova demonstrated efficacy, with statistical significance compared to a placebo, officials said.

In addition, both dose regimens achieved statistical significance in other measures of effectiveness. These secondary endpoints included increased number of peri-menstrual periods with one or no days of mild headache, reduction in headache intensity and a reduction in the use of rescue medication. There were no serious adverse events attributed to Frova, officials said.

Vernalis is a Winnersh, England, specialty biopharmaceutical company focused on products marketed to specialist neurologists.

Endo is a Chadds Ford, Pa., specialty pharmaceutical company with a focus on pain management products.

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