Endo Pharmaceuticals, Vernalis file supplemental NDA for Frova

By Jennifer Chiou

New York, July 19 - Endo Pharmaceuticals Holdings Inc. and Vernalis plc announced that Endo submitted a supplemental New Drug Application for Frova to the FDA.

Frova is for the short-term prevention of menstrual migraine.

The companies said that the submission contains positive data from previously reported phase 3 studies.

Endo and Vernais added that Frova, which is already approved for the treatment of migraine attacks, would be the only triptan indicated in the United States for the prevention of menstrual migraine, if approved.

"Doctors and patients need to understand that menstrual migraine differs from other kinds of migraines. These differences need to be taken into consideration in order for the condition to be treated appropriately," said Stephen Silberstein, lead investigator of the initial efficacy study of Frova, in a news release.

Vernalis is a specialty pharmaceutical company based in Morristown, N.J., focused on drugs for the treatment of neurology and central nervous system disorders.

Endo is a Chadds Ford, Pa., specialty pharmaceutical company.

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