Do Your Patients Have Migraines That Are Long in Duration and/or Recur?

Transcription

1 Do Your Patients Have s That Are Long in Duration and/or Recur?

2 attacks Can Be FROVA and often Was recur Generally 1-4 Well Characteristics associated with migraines that are long in duration and/or recur symptoms may last up to 72 hours 1,3 In one clinical study, it was documented that 65.6% of patients had headache duration up to 24 hours 1 The same study reported that 34.4% of patients experienced headache that lasted 24 to 72 hours 1 Long in Duration, Of the estimated nearly 30 million Americans who suffer migraines, approximately 21 million are women 5,6 Common signs and symptoms of a migraine attack with or without aura may include 3 : Unilateral head pain and aching Light sensitivity Nausea Vomiting Vision change Sound sensitivity LOnG in DuRAtiOn Additionally, a substantial number of patients (43.8%) reported headache recurrence after initial relief 1 Recurrence is generally defined as the return of a migraine within 24 hours after initial relief 2,4 FROVA (frovatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura in adults. FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominantly male population. FROVA should not be given to patients with ischemic heart disease (eg, angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal s variant angina, or other significant underlying cardiovascular disease. Please see the accompanying full Prescribing Information. 2 3

3 Proven Efficacy 7 Treatment with FROVA resulted in significant reductions in headache at 2 and 4 hours 7 In 3 randomized, double-blind, pivotal clinical studies, the 2-hour headache response was significantly greater in patients treated with FROVA vs placebo 7 Headache response at 2 hours and 4 hours 7 Percentage of Patients 70 65% 56% 62% % 46% 21% 27% 23% 37% 38% 40 31% 32% 30 Placebo 20 FROVA 10 0 P Study 1 Study 2 Study 3 Study 1 Study 2 Study 3 2 hours 4 hours proven efficacy Adapted from Ryan R et al. Headache. 2002;42(suppl 2):S84-S92. 7 Pain-free response at 2 hours and 4 hours 7 Percentage of Patients 40 32% 31% 27% 30 * * 14% * 20 13% 9% 14% * * 10% 9% 10 2% 3% 3% 0 Study 1 Study 2 Study 3 Study 1 Study 2 Study 3 2 hours 4 hours Adapted from Ryan R et al. Headache. 2002;42(suppl 2):S84-S92. 7 Placebo FROVA *P P 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 FROVA 2.5 mg for the acute treatment of migraine. 7 FROVA (frovatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura in adults. FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominantly male population. FROVA should not be given to patients with: cerebrovascular syndromes including (but not limited to) strokes of any type and transient ischemic attacks; peripheral vascular disease including (but not limited to) ischemic bowel disease; uncontrolled hypertension; hemiplegic or basilar migraine; hypersensitivity to frovatriptan or any of the inactive ingredients in the tablets. FROVA should not be used within 24 hours of treatment with another 5-HT 1 agonist, an ergotamine containing, or ergot-type medication such as dihydroergotamine (DHE) or methysergide. Please see for female the accompanying migraine sufferers full Prescribing Information. 4 5

4 Lasting Relief 8 In a separate study with FROVA, responders experienced low recurrence* rates through 24 hours 8 Pain free at 4 hours through to 24 hours 8 Percentage of Patients % Pain free at 4 hours FROVA late { Of the 44%, 94 % remained pain free through 24 hours Adapted from Cady R et al. Curr Med Res Opin. 2004;20(9): 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). 8 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) 8 * 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. 8 Pain free was defined as no migraine headache (Grade 0) hour sustained pain-free response was defined as pain free with no remedication and no recurrence. 8 The most common adverse events experienced in all treatment groups were dry mouth, dizziness, and drowsiness % Pain free at 4 hours P =0.003 FROVA early { Of the 58%, 96 % (n=241) remained pain free through 24 hours FROVA (frovatriptansuccinate)isindicatedfortheacute treatmentofmigraineattackswithorwithoutaurainadults. FROVAisnotintendedfortheprophylactictherapyofmigraine orforuseinthemanagementofhemiplegicorbasilarmigraine. ThesafetyandeffectivenessofFROVAhavenotbeen establishedforclusterheadache,whichispresentinan older,predominantlymalepopulation. FROVAshouldnotbegiventopatientswith:cerebrovascular syndromesincluding(butnotlimitedto)strokesofanytype andtransientischemicattacks;peripheralvasculardisease including(butnotlimitedto)ischemicboweldisease; uncontrolledhypertension;hemiplegicorbasilarmigraine; hypersensitivitytofrovatriptanoranyoftheinactive ingredientsinthetablets. FROVAshouldnotbeusedwithin24hoursoftreatment withanother5-ht 1 agonist,anergotaminecontaining,or ergot-typemedicationsuchasdihydroergotamine(dhe) ormethysergide. Please see the accompanying full Prescribing Information. Lasting ReLief 6 7

5 FROVA Has a Long Elimina tion Half-life of Approximately 26 Hours 9 FROVA Hours Triptan class of drugs has a range of elimination half-lives* between 2.5 and 26 hours 10,11 * A correlation between elimination half-life and clinical efficacy has not been established. FROVA should only be used when a clear diagnosis of migraine has been established. Serious cardiac events, including some that have been fatal, have occurred following use of 5-HT 1 agonists. Because of the potential of this class of compound (5-HT 1 agonists) to cause coronary vasospasm, FROVA should not be given to patients with documented ischemic or vasospastic coronary artery disease. References: 1. Kelman L. Pain characteristics of the acute migraine attack. Headache. 2006;46(6): Malik SN, Hopkins M, Young WB, Silberstein SD. Acute migraine treatment: patterns of use and satisfaction in a clinical population. Headache. 2006;46(5): Headache Classification Subcommittee of the International Headache Society (IHS). The international classification of headache disorders. Cephalalgia. 2004;24(suppl 1): Guidelines for controlled trials of drugs in migraine. 1st ed. International Headache Society Committee on Clinical Trials in. Cephalalgia.1991; 11(1): Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Study II. Headache. 2001;41(7): US Department of Health and Human Services, Office on Women s Health.. Accessed June 29, Ryan R, Geraud G, Goldstein J, Cady R, Keywood C. Clinical efficacy of frovatriptan: placebo-controlled studies. Headache. 2002;42(suppl 2): S84-S 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 or severe. Curr Med Res Opin. 2004;20(9): FROVA [package insert]. Chadds Ford, PA: Endo Pharmaceuticals; Physicians Desk Reference. 63rd ed. Montvale, NJ: Physicians Desk Reference Inc; RELPAX [package insert]. New York, NY: Pfizer Inc; HOuR HALF-LiFE Please see the accompanying full Prescribing Information. 8 9

6 MeNSTrUal MiGraiNe attacks Can Be FROVA and often Was recur Generally 1-4 Well Tolerated in Clinical Trials 9 Adverse event profile similar to that of placebo Most common FROVA Placebo adverse events* 9 (n=1554) (n=838) Dizziness 8% 5% Fatigue 5% 2% Paresthesia 4% 2% Flushing 4% 2% Headache 4% 3% Dry mouth 3% 1% Hot or cold sensation 3% 2% Skeletal pain 3% 2% Chest pain 2% 1% Dyspepsia 2% 1% In clinical trials, only 1% of patients withdrew due to adverse events. 9 * Incidence 2% and greater than placebo among patients in 4 placebo-controlled trials. Clinical pharmacology Cytochrome P450 1A2 appears to be the principal enzyme involved in the metabolism of frovatriptan 9 Frovatriptan is not an inhibitor of human monoamine oxidase (MAO) enzymes or cytochrome P450 in vitro 9 Although no clinical studies have been performed, it is unlikely that frovatriptan will affect the metabolism of co-administered drugs metabolized by MAO enzymes or cytochrome P450 9 In a preclinical (animal) study, frovatriptan produced selective constriction of the carotid vascular bed 9 FROVA should only be used when a clear diagnosis of migraine has been established. Serious cardiac events, including some that have been fatal, have occurred following use of 5-HT 1 agonists. Because of the potential of this class of compound (5-HT 1 agonists) to cause coronary vasospasm, FROVA should not be given to patients with documented ischemic or vasospastic coronary artery disease. FROVA should not be given to patients within whom unrecognized coronary artery disease is predicted by the presence of coronary risk factors unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or any other significant cardiovascular disease. For patients who are determined to have a satisfactory cardiovascular evaluation, administration of the first dose of FROVA should take place under the supervision of a physician. Patients who are intermittent long-term users of 5-HT 1 agonists, including FROVA, and who have or acquire risk factors predictive of coronary artery disease should undergo periodic cardiovascular evaluations while taking FROVA. The development of a potentially life-threatening serotonin syndrome may occur with triptans, including FROVA treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). If concomitant treatment with FROVA and an SSRI or SNRI is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases. Please see the accompanying full Prescribing Information SafeTy profile

7 treat s that are long in Duration and/or recur With frova In pivotal studies with FROVA, 2-hour headache response was significantly greater in patients treated with FROVA when compared to placebo 7 Early use of FROVA resulted in: Proven pain-free response at 2 hours and lasting relief up to 24 hours 8 Low headache recurrence up to 24 hours in responders 8 Higher rates of 24-hour sustained pain-free response 8 FROVA was generally well tolerated 9 FROVA (frovatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura in adults. FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominantly male population. FROVA should not be given to patients with ischemic heart disease (eg, angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal s variant angina, or other significant underlying cardiovascular disease. The most common adverse events occurring with the use of FROVA were dizziness, paresthesia, headache, dry mouth, fatigue, flushing, hot or cold sensation, and chest pain. Please see the accompanying full Prescribing Information for FROVA and insert. FROVA is a registered trademark of Vernalis Development Limited. ChADDs FORD, PENNsyLVANiA Endo Pharmaceuticals. All Rights Reserved. FR-0389/July ENDO (3636)

8 Up to an Estimated 60% of the 21 Million US Female Sufferers Experience s Around the Time of Their Period and at Other Times of the Month 1-4 Pure Menstrual (migraine during menstruation days 2 through +3)* Menstrual without aura can be either 5 MONTH S M T W TH F S Period X XX Menstrual Window Menstrual s have been reported to Persist longer up to 72 hours 5-7 Be more likely to recur 7 Be more resistant to treatment 3,6,7 Occur with greater severity 6,8 Be more likely to be accompanied by nausea and vomiting 3,8 Menstrually Related (migraine during menstruation days 2 through +3 and other times of the month)* MONTH S M T W TH F S XX XXX XX Period Menstrual Window Compared with migraines that occur at other times of the month. s are generally predictable Evidence suggests Menstrual s are strongly associated with hormone changes that naturally occur during a monthly menstrual cycle 5,9 *In at least 2 out of 3 menstrual cycles. Menstruation may increase the risk of occurrence of migraine by up to 96%. 10 This was a prospective study in which factors related to migraine attacks were analyzed using diary data from 327 adult migraineurs over 3 months. The hazard for occurrence and persistence of migraine was determined by univariate Cox regression analyses and 2 stepwise multivariate Cox regression analyses for those covariables that showed a P value of < 0.05 in the univariate analyses. 10 FROVA (frovatriptan succinate) is indicated for the acute treatment of migraine attacks with or without aura in adults. FROVA is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. The safety and effectiveness of FROVA have not been established for cluster headache, which is present in an older, predominantly male population. FROVA should not be given to patients with ischemic heart disease (eg, angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal s variant angina, or other significant underlying cardiovascular disease. FROVA should not be given to patients with: cerebrovascular syndromes including (but not limited to) strokes of any type and transient ischemic attacks; peripheral vascular disease including (but not limited to) ischemic bowel disease; uncontrolled hypertension; hemiplegic or basilar migraine; hypersensitivity to frovatriptan or any of the inactive ingredients in the tablets. Please see the accompanying full Prescribing Information.

9 Do Your Patients Have s That Are Long in Duration and/or Recur? My migraine comes back over the course of a day. Just when I think I ve found lasting relief, severe pain returns within 4 hours. Occupation Kindergarten teacher history has suffered from migraines since she was 18 years of age suffers from migraines both during and outside of her period Often experiences nausea and vomiting with her migraine Frequently experiences recurring migraine pain during a 24-hour period, even after treatment Occasionally misses work because of migraines Current migraine treatment Uses prescription drugs but reports that migraines frequently recur, requiring redosing References: 1. Lipton RB, Stewart WF, Diamond S, Diamond ML, Reed M. Prevalence and burden of migraine in the United States: data from the American Study II. Headache. 2001;41(7): Granella F, Sances G, Zanferrari C, Costa A, Martignoni E, Manzoni GC. without aura and reproductive life events: a clinical epidemiological study in 1300 women. Headache. 1993;33(7): Dzoljic E, Sipetic S, Vlajinac H, et al. Prevalence of menstrually related migraine and nonmigraine primary headache in female students of Belgrade University. Headache. 2002;42(3): Granella F, Sances G, Pucci E, Nappi RE, Ghiotto N, Nappi G. with aura and reproductive life events: a case control study. Cephalalgia. 2000;20(8): Headache Classification Subcommittee of the International Headache Society (IHS). The international classification of headache disorders. Cephalalgia. 2004;24(suppl 1): Couturier EG, Bomhof MA, Neven AK, van Duijn NP. Menstrual migraine in a representative Dutch population sample: prevalence, disability and treatment. Cephalalgia. 2003;23(4): 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): MacGregor EA, Hackshaw A. Prevalence of migraine on each day of the natural menstrual cycle. Neurology. 2004;63(2): 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): 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): only FROVA is a registered trademark of Vernalis Development Limited. Chadds Ford, Pennsylvania Endo Pharmaceuticals. All Rights Reserved. FR-0389A/July ENDO (3636)