Endo Pharmaceuticals has released data from the second Phase III study of Frova® (frovatriptan succinate) for the short-term (six days per month) prevention of menstrual Migraine (MM). This study corroborates the positive findings in a prior efficacy study published in Neurology in July 2004. Now, with two successful Phase III trials, 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® for the prevention of menstrual Migraine. If the application approved, Frova® will be the only triptan in the U.S. actually FDA-approved for the prevention of MM. Frova® is was approved by the FDA in 2001 "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... Menstrual Migraine sufferers deserve a treatment tailored to their condition." stated Stephen D, Silberstein, M.D., professor of neurology at the Jefferson Medical College of Thomas Jefferson University, director of the Jefferson Headache Center. Dr. Silberstein was lead investigator of the first Phase III trial of Frova® for the short-term prevention of menstrual Migraine.
Study Eligibility:
To be eligible for this study, patients had to have previously tried medications
other than triptans (such as NSADs) for the prevention of MM and to have
responded inadequately to triptans for MM.
Study Methods:
- Patients were treated for three perimenstrual periods.
- The primary endpoint was the number of menstrual-Migraine-free perimenstrual periods.
- Both once- and twice-daily regimens of Frova® were tested.
Study Results:
- Both once- and twice-daily regimens of Frova® demonstrated statistical significance in producing perimenstrual periods with one or no days of mild Migraine.
- Use of Frova® also produced a reduction in Migraine intensity.
- Study participants also reported a reduction in the use of rescue medication.
- There were no serious adverse events attributed to Frova®.
- The frequency of other adverse events was similar in the groups receiving Frova® and placebo.
Statistics show that menstrual Migraines affect up to 6% of women with Migraine disease. For more information about menstrual Migraines, please see Menstrual Migraines: the Hormonal Impact.
