Vernalis PLC Regulatory News (VER)

8 May 2006 07:02

Vernalis PLC08 May 2006 For Immediate Release Frova(R) Meets Primary Endpoint in Second Phase III Study for Prevention of Menstrual Migraine --Data to be Included as Part of Supplemental NDA to FDA-- WINNERSH, U.K., and CHADDS FORD, Pa., May 8, 2006 -- Vernalis plc (LSE: VER,Nasdaq: VNLS) and Endo Pharmaceuticals Holdings Inc. (Nasdaq: ENDP) todayannounced 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 thepositive findings in a prior efficacy study published in Neurology in July 2004(ref: 2004, 63: 261-269). Endo expects to file a supplemental New DrugApplication (sNDA) with the U.S. Food and Drug Administration (FDA) in thecoming weeks to seek approval for the additional indication of Frova(R) for theprevention of menstrual migraine. If approved, Frova(R) will be the only triptan indicated in the US for theprevention of MM. Frova(R) is FDA-approved for the acute treatment of migraineattacks with or without aura in adults where a clear diagnosis of migraine hasbeen established. "Menstrual migraines can have significant impact on a woman's life. Thepreliminary results of this study are encouraging for women who suffer frommenstrual migraine and who have not responded well to acute treatment," said thelead investigator in the trial, Jan Lewis Brandes, M.D., of the NashvilleNeuroscience Group and of the Department of Neurology at Vanderbilt UniversitySchool 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," statedStephen Silberstein, M.D., professor of neurology at the Jefferson MedicalCollege of Thomas Jefferson University, director of the Jefferson HeadacheCenter and lead investigator of the initial efficacy study of Frova(R) for theshort-term prevention of menstrual migraine. "Menstrual migraine sufferersdeserve a treatment tailored to their condition." Study Results Patients in the study were treated for three peri-menstrual periods (PMPs) andthe primary endpoint was the number of menstrual migraine-free PMPs. Both onceand twice-daily dose regimens of Frova(R) demonstrated efficacy, withstatistical significance compared to placebo (p