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

CHICAGO, IL, Jun 09, 2007 (MARKET WIRE via COMTEX News Network) -- Endo Pharmaceuticals Inc., a wholly owned subsidiary of Endo Pharmaceuticals Holdings Inc. (NASDAQ: ENDP), has presented results from a Phase III randomized, double-blind, placebo-controlled clinical trial evaluating Frova (frovatriptan succinate) 2.5 mg tablets as a six-day preventative treatment in women with difficult-to-treat menstrual migraine (MM). The data demonstrated that FROVA significantly reduced the frequency and severity of MM as well as the disabilities related to them. The results, which were presented here today at the annual meeting of the American Headache Society (AHS), were from the second of the two successful Phase III placebo-controlled clinical trials evaluating the efficacy and safety of FROVA in MM prophylaxis.
Women receiving FROVA started the six-day regimen two days prior to the onset of their anticipated headache. Starting treatment two days before the expected headache ensures that patients have adequate blood levels at the time they usually start to experience MM, and continuing treatment for six days ensures that they are covered during the whole period when they are likely to experience those headaches. Women in the study had responded poorly to previous acute triptan treatment for MM.

"In this study, appropriately timed short-term treatment with FROVA prevented or significantly reduced the pain of difficult-to-treat but often predictable migraines associated with the menstrual period," said the lead investigator in the trial, Jan Lewis Brandes, M.D., of the Nashville Neuroscience Group and assistant clinical professor of the Department of Neurology at Vanderbilt University School of Medicine. "This is exciting news for women and their physicians who need to realize that the debilitating pain of menstrual migraine is not inevitable and is not a normal part of their menstrual cycle."

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