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Efficacy

In a clinical trial, a proportion of patients with mild or no headache at 2 hours and 4 hours postdose6

This was a multicenter, double-blind, placebo-controlled, 2-way crossover study to prospectively evaluate whether FROVA would provide greater relief if given early during a migraine attack. Patients recorded migraine severity at fixed time-points postdose (at 1, 2, 3, 4, and 24 hours).6

Significantly more patients treated early were pain free at 2 hours after treatment — 28% of patients treated early with FROVA vs. 20% of patients treated with placebo (P = 0.04)6


In 3 randomized, double-blind pivotal clinical studies

2-hour headache response was significantly greater in patients treated with FROVA, as compared to placebo (P ≤0.001)7

These were 3 randomized, placebo-controlled, double-blind, parallel-group trials, in a total of 2676 patients, and were performed to confirm the clinical efficacy of frovatriptan 2.5 mg for the acute treatment of migraine.7

The most common side effects associated with the use of FROVA are dizziness, fatigue, paresthesia, flushing, headache, dry mouth, hot or cold sensation, skeletal pain, chest pain, and dyspepsia.
+ View references
  1. Kelman L. Pain characteristics of the acute migraine attack. Headache. 2006;46(6):942-953. doi:10.1111/j.1526-4610.2006.00443.x.
  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. doi:10.1111/j.1526-4610.2006.00437.x.
  3. Headache Classification Subcommittee of the International Headache Society (IHS). The international classification of headache disorders, 2nd edition, 1st revision (ICHD-IIR1). http://ihs-classification.org/_downloads/mixed/ICHD-IIR1final.doc. Updated May 2005. Accessed March 5, 2009.
  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. 63rd ed. Montvale, NJ: Physicians' Desk Reference Inc; 2008.
  10. RELPAX® [package insert]. New York, NY: Pfizer Inc. Available online at: https://www.pfizerpro.com/product_info/relpax_pi_clinical_pharmacology.jsp. Accessed January 8, 2009.
     

    Important Safety Information

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