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Frova Phase III Study Data Demonstrates That Short-Term Prevention,Treatment Reduces Frequency and Severity of Menstrual Migraine

ly), photophobia, and phonophobia (p < 0.008; BID and QD vs. placebo), and patients experienced significantly less functional impairment during treatment with FROVA (p < 0.0001; QD and BID vs. placebo).

Both FROVA regimens were equally well tolerated with a low rate of adverse events. The most commonly reported adverse events were upper respiratory tract infection (37 patients), nausea (36 patients), and dizziness (31 patients). Most adverse events were rated mild or moderate in severity and did not increase in severity with increasing doses of FROVA; the percentage rated severe was 19 percent in the placebo group and 22 percent (once daily) and 14 percent (twice daily) in the FROVA groups.

Endo has submitted a supplemental New Drug Application (sNDA) for FROVA 2.5 mg tablets for the short-term (six days per month) prevention of MM to the U.S. Food and Drug Administration (FDA).

About Menstrual Migraine

Menstrual migraine, distinct from other types of migraines, is largely an under-recognized condition. Of the approximately 21 million women in the U.S. who experience migraines, up to 60 percent suffer from MM and its debilitating effects. More than half of these women, however, may not be correctly diagnosed, and therefore may not be receiving adequate treatment. MM has been reported to be more severe and last longer than other migraines, and women who suffer from MM may experience significant restrictions in their daily activities. For many women with MM, currently available treatment options may not adequately reduce the debilitating symptoms, such as pain, nausea and vomiting, nor the migraine's duration. For more information about MM, visit www.menstrualmigraine.org.

Important Information about FROVA

FROVA is indicated for the acute treatment of migraine attacks with or without aura in adults. FROVA is not intended for the prophylactic therapy of migraine o
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