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Frova®: Trial for Menstrual Migraine Successful

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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.

The hormonal fluctuations around the menstrual period are a common Migraine trigger for many women. In survey conducted by the National Headache Foundation, 87% of respondents reported that their Migraines increase in frequency and/or severity before, during, or immediately after their menstrual cycle.

Menstrual Migraine (MM) can be divided into two types:

  • In Menstrually-Related Migraine (MRM) the Migraine attack usually included headache of moderate to severe pain that and occurs during a certain window of time around the period and at other times of the month as well.
  • In Pure Menstrual Migraine (PMM) the attacks are every respect, but occur during the time around a woman’s period only.

For more information about menstrual Migraine and possible treatments, please see:


Press Release. "Frova(R) Meets Primary Endpoint in Second Phase III Study for Prevention of Menstrual Migraine." Vernalis plc and Endo Pharmaceuticals Holdings Inc. Winnersh, England and Chadds FORD, Pa., May 8.

Press Release. "Hormonal Impact on Menstrual Migraines." National Headache Foundation. Chicago. May 3, 2006.


Published May 8, 2006
© Teri Robert


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