Frova for Menstrual Migraine FDA Application Withdrawn

FDA Application Withdrawn for FROVA for Prevention of Menstrual Migraines

Apr 7, 2008 -- Endo Pharmaceuticals Inc., today announced that it has notified the U.S. Food and Drug Administration (FDA) of the withdrawal of the supplemental new drug application for the additional indication of FROVA for the short-term (six days a month) prevention of menstrual migraine. FROVA is already approved and marketed for the acute treatment of migraine with or without aura in adults where a clear diagnosis of migraine has been established.

"The decision to withdraw the unapproved supplemental application was complex; however, after a lengthy and detailed evaluation of the points raised in the FDA 'not approvable' letter, we have determined the withdrawal to be the appropriate course of action at this time," said Dave Holveck, Endo President and Chief Executive Officer. "We appreciate the guidance from the FDA during the development program and its comprehensive review of the supplemental application."

This does not come as a great shock to me. FROVA and other triptans are considered to be vasoconstriction drugs. The source cause of migraines is not the same as the reason your head hurts when you have a migraine. Triptans are used to abort a migraine in progress.

Our research has indicated that menstrual migraines, as do the majority of all migraines, occur in a direct relationship to the hormone production that is controlled by secretions through the endocrine system. This is why most migraines for women occur during the three days prior to the start of the actual period, the day after the flow stops, and at ovulation.

Therefore, based on our research, prevention of menstrual migraines is best served by the management of the cause of menstrual migraines long before they can become a pain in the head.

Don’t ever give up - Migraines Can Be Prevented.

Lyle

Tuliv Migraine Research