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Associated Symptoms

Relief of Associated Symptoms FROVA vs. placebo
Nausea
Study 1
Study 2
Study 3 		P value, 2 hours
 0.092a 
 0.116a 
 0.007
P value, 4 hours
<0.001  
<0.001  
<0.001  
Photophobia
Study 1
Study 2
Study 3 		P value, 2 hours
 0.001  
<0.001  
 0.01  
P value, 4 hours
 0.001  
<0.001  
<0.001  
Phonophobia
Study 1
Study 2
Study 3 		P value, 2 hours
 0.018  
 0.012  
 0.016a 
P value, 4 hours
<0.001  
<0.001  
 0.002  

Adapted from Ryan et al. Headache. 2002;42(suppl 2):S84-S92.7

a Not statistically significant.

Three randomized, double-blind, placebo-controlled, parallel-group trials in 2676 patients, were performed to confirm clinical efficacy of FROVA® for acute treatment of migraine. Patients recorded migraine severity and associated symptoms at 0, 2, 4, 6, 12, and 24 hours postdose.7

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
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  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.
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  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.