Frova(R) Meets Primary Endpoint in Second Phase III Study for Prevention of Menstrual Migraine

Share Name	Share Symbol	Market	Type
Vernalis Plc ADS (MM)	NASDAQ:VNLS	NASDAQ	Common Stock

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Frova(R) Meets Primary Endpoint in Second Phase III Study for Prevention of Menstrual Migraine

08/05/2006 8:00am

PR Newswire (US)

Vernalis (NASDAQ:VNLS)
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- Data to be Included as Part of Supplemental NDA to FDA - WINNERSH, England and CHADDS FORD, Pa., May 8 /PRNewswire-FirstCall/ -- Vernalis plc (LSE:VERLSE:Nasdaq:LSE:VNLS) and Endo Pharmaceuticals Holdings Inc. (NASDAQ:ENDP) today announced top-line data from the second Phase III efficacy study of Frova(R) (frovatriptan succinate) 2.5 mg tablets for the short-term (six-days per month) prevention of menstrual migraine (MM). The data from this study corroborate the positive findings in a prior efficacy study published in Neurology in July 2004 (ref: 2004, 63: 261-269). Endo expects to file a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) in the coming weeks to seek approval for the additional indication of Frova(R) for the prevention of menstrual migraine. If approved, Frova(R) will be the only triptan indicated in the US for the prevention of MM. Frova(R) 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, M.D., of the Nashville Neuroscience Group and of the Department of Neurology at Vanderbilt University School of Medicine. "There is an unmet need for a new treatment option that is well-tolerated, effective and capable of preventing menstrual migraine from occurring," stated Stephen Silberstein, M.D., professor of neurology at the Jefferson Medical College of Thomas Jefferson University, director of the Jefferson Headache Center and lead investigator of the initial efficacy study of Frova(R) for the short-term prevention of menstrual migraine. "Menstrual migraine sufferers deserve a treatment tailored to their condition." Study Results Patients in the study were treated for three peri-menstrual periods (PMPs) and the primary endpoint was the number of menstrual migraine-free PMPs. Both once and twice-daily dose regimens of Frova(R) demonstrated efficacy, with statistical significance compared to placebo (p

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VNLS Vernalis Plc ADS (MM)