Home  |  Important Safety Information  |  Full Prescribing Information PDF
Contact Us  |  Site Map
A
A
A
Print

Recurrence

Pain free† at 4 hours through to 24 hours6

This was a multicenter, double-blind, placebo-controlled, 2-way crossover study in 241 patients to prospectively evaluate whether FROVA would provide greater relief if given early during a migraine attack. During the first 2 hours of the study, patients were treated with FROVA (FROVA early) or placebo; thereafter, patients in the placebo group were allowed to dose with FROVA (FROVA late group). Patients recorded migraine severity at fixed time-points postdose (at 1, 2, 3, 4, and 24 hours).6

Patients who received FROVA early had higher rates of 24-hour sustained pain-free response‡ than the late group (40% vs 31%; P<0.05)6

* Recurrence was defined as patients who were pain free at 4 hours but reported a return of headache of any severity (Grade 1, 2, or 3) within 24 hours.6
† Pain free was defined as no migraine headache (Grade 0).6
‡ 24-hour sustained pain-free response was defined as pain free with no remedication and no recurrence.6

The most common adverse events experienced in all treatment groups were dry mouth, dizziness, and drowsiness.6

For more information, please see Full Prescribing Information for FROVA at http://www.frova.com/pi.

If you are a Vermont prescriber, additional information is available.

References
  1. Kelman L. Pain characteristics of the acute migraine attack. Headache. 2006;46(6):942-953.
  2. Malik SN, Hopkins M, Young WB, Silberstein SD. Acute migraine treatment: patterns of use and satisfaction in a clinical population. Headache. 2006;46(5):773-780.
  3. Headache Classification Subcommittee of the International Headache Society (IHS). The international classification of headache disorders. Cephalalgia. 2004;24(suppl 1):8-160.
  4. Guidelines for controlled trials of drugs in migraine. First edition. International Headache Society Committee on Clinical Trials in Migraine. Cephalalgia. 1991;11(1):1-12.
  5. Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Migraine Study II. Headache. 2001;41(7):646-657.
  6. Cady R, Elkind A, Goldstein J, Keywood C. Randomized, placebo-controlled comparison of early use of frovatriptan in a migraine attack versus dosing after the headache has become moderate to severe. Curr Med Res Opin. 2004;20(9):1465-1472. doi:10.1185/030079904X2745.
  7. Ryan R, Geraud G, Goldstein J, Cady R, Keywood C. Clinical efficacy of frovatriptan: placebo-controlled studies. Headache. 2002;42(suppl 2):S84-S92.
  8. FROVA® [package insert]. Chadds Ford, PA: Endo Pharmaceuticals, Inc; 2007.
  9. Physicians' Desk Reference. 65th ed. Montvale, NJ: Physicians' Desk Reference Inc; 2011.
  10. RELPAX® [package insert]. New York, NY: Pfizer Inc; 2008.
  11. Granella F, Sances G, Zanferrari C, Costa A, Martignoni E, Manzoni GC. Migraine without aura and reproductive life events: a clinical epidemiological study in 1300 women. Headache. 1993;33(7):385-389.
  12. Dzoljic E, Sipetic S, Vlajinac H, et al. Prevalence of menstrually related migraine and nonmigraine primary headache in female students of Belgrade University. Headache. 2001;42(3):185-193.
  13. Granella F, Sances G, Pucci E, Nappi RE, Ghiotto N, Nappi G. Migraine with aura and reproductive life events: a case control study. Cephalalgia. 2000;20(8):701-707.
  14. Couturier EG, Bomhof MA, Neven AK, van Dukin NP. Menstrual migraine in a representative Dutch population sample: prevalence, disability and treatment. Cephalalgia. 2003;23(4):302-308.
  15. Granella F, Sances G, Allais G, et al. Characteristics of menstrual and nonmenstrual attacks in women with menstrually related migraine referred to headache centres. Cephalalgia. 2004;24(9):707-716.
  16. MacGregor EA, Hackshaw A. Prevalence of migraine on each day of the natural menstrual cycle. Neurology. 2004;63(2):351-353.
  17. MacGregor EA, Frith A, Ellis J, Aspinall L, Hackshaw A. Incidence of migraine relative to menstrual cycle phases of rising and falling estrogen. Neurology. 2006;67(12):2154-2158.
  18. Wober C, Brannath W, Schmidt K, et al; for the PAMINA Study Group. Prospective analysis of factors related to migraine attacks: the PAMINA study. Cephalalgia. 2007;27(4):304-314.
  19. US Department of Health and Human Services, Office on Women's Health. Migraine. http://www.womenshealth.gov/faq/migraine.pdf. Accessed June 29, 2010.