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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:
___________________
Resources:
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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