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

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(1)

Do Your Patients

Have Migraines That

Are Long in Duration

(2)

Migraine attacks Can Be

and often recur

1-4

Characteristics associated with

migraines that are long in

duration and/or recur

Migraine 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

• 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

2

L403524_Cover_PF.indd 4 7/20/10 12:33 PM

FROVA first for female migraine sufferers

FROVA

®

Was Generally Well

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

Indication

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.

Important Safety Information

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.

3 LO n G in Du RA ti O n FRO024_Slim_Jim_PF.indd 2 7/19/10 2:13 PM

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P er cent age of Patients Placebo FROVA *P≤0.001. †P≤0.01. 2 hours

Study 1 Study 2 Study 3 Study 1 Study 2 Study 3

4 hours 14% 3% 2% 13% 3% 9% 10% 27% 14% 32% 9% 31% 40 30 20 10 0

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

* * * * * P er cent age of Patients Placebo FROVA P≤0.001. 2 hours

Study 1 Study 2 Study 3 Study 1 Study 2 Study 3

4 hours 39% 27% 21% 46% 23% 37% 31% 56% 38% 65% 32% 62% 70 30 40 50 60 20 10 0

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

Proven Efficacy

7

Treatment with FROVA

®

resulted in significant reductions in headache

at 2 and 4 hours

7

4

In 3 randomized, double-blind, pivotal clinical studies, the 2-hour headache response was

significantly greater in patients treated with FROVA vs placebo

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 FROVA 2.5 mg for the acute treatment of migraine.7

Headache response at 2 hours and 4 hours

7

Pain-free response at 2 hours and 4 hours

7

Indication

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.

L403524_Slim_Jim.indd 3 7/20/10 5:53 PM P er cent age of Patients Placebo FROVA *P≤0.001. †P≤0.01. 2 hours

Study 1 Study 2 Study 3 Study 1 Study 2 Study 3

4 hours 14% 3% 2% 13% 3% 9% 10% 27% 14% 32% 9% 31% 40 30 20 10 0

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

* * * * * P er cent age of Patients Placebo FROVA P≤0.001. 2 hours

Study 1 Study 2 Study 3 Study 1 Study 2 Study 3

4 hours 39% 27% 21% 46% 23% 37% 31% 56% 38% 65% 32% 62% 70 30 40 50 60 20 10 0

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

FROVA first for female migraine sufferers

Treatment with FROVA

®

resulted in significant reductions in headache

at 2 and 4 hours

7

5

In 3 randomized, double-blind, pivotal clinical studies, the 2-hour headache response was

significantly greater in patients treated with FROVA vs placebo

7

Important Safety Information

• 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-HT1 agonist, an ergotamine containing, or

ergot-type medication such as dihydroergotamine (DHE) or methysergide.

Please see the accompanying full Prescribing Information.

proven

efficacy

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

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0 20 40 60 80

FROVA early

P

ercentage

of

P

atients

Of the 58%,

96

%

remained

pain free

through 24 hours

Of the 44%,

94

%

remained

pain free

through 24 hours

FROVA late

58

%

Pain free at 4 hours

P=0.003

44

%

Pain free at 4 hours

{

{

(n=241)

Adapted from Cady R et al. Curr Med Res Opin. 2004;20(9):1465-1472.8

Pain free

at 4 hours through to 24 hours

8

6

In a separate study with FROVA

®

, responders experienced low recurrence*

rates through 24 hours

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).8 ‡ 24-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.

8

Lasting Relief

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

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

L403524_Slim_Jim.indd 5 7/20/10 11:54 AM

FROVA first for female migraine sufferers

0 20 40 60 80

FROVA early

P

ercentage

of

P

atients

Of the 58%,

96

%

remained

pain free

through 24 hours

Of the 44%,

94

%

remained

pain free

through 24 hours

FROVA late

58

%

Pain free at 4 hours

P=0.003

44

%

Pain free at 4 hours

{

{

(n=241)

Adapted from Cady R et al. Curr Med Res Opin. 2004;20(9):1465-1472.8

7

Indication

FROVA®(frovatriptansuccinate)isindicatedfortheacute treatmentofmigraineattackswithorwithoutaurainadults. FROVAisnotintendedfortheprophylactictherapyofmigraine orforuseinthemanagementofhemiplegicorbasilarmigraine. ThesafetyandeffectivenessofFROVAhavenotbeen establishedforclusterheadache,whichispresentinan older,predominantlymalepopulation.

Important Safety Information

•FROVAshouldnotbegiventopatientswith:cerebrovascular syndromesincluding(butnotlimitedto)strokesofanytype andtransientischemicattacks;peripheralvasculardisease including(butnotlimitedto)ischemicboweldisease; uncontrolledhypertension;hemiplegicorbasilarmigraine; hypersensitivitytofrovatriptanoranyoftheinactive ingredientsinthetablets. •FROVAshouldnotbeusedwithin24hoursoftreatment withanother5-HT1agonist,anergotaminecontaining,or ergot-typemedicationsuchasdihydroergotamine(DHE) ormethysergide.

Please see the accompanying full Prescribing Information.

In a separate study with FROVA

®

, responders experienced low recurrence*

rates through 24 hours

8

L asting R e L ief

(5)

Hours

0

5

10

15

20

25

30

FROVA

FROVA

®

Has a Long Elimina tion Half-life

of Approximately 26 Hours

9

8

* A correlation between elimination half-life

and clinical efficacy has not been established.

Important Safety Information

• 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-HT1 agonists. Because of the potential of this class of compound (5-HT1 agonists) to

cause coronary vasospasm, FROVA should not be given to

patients with documented ischemic or vasospastic coronary artery disease.

Please see the accompanying full Prescribing Information.

• Triptan class of drugs has a range of elimination half-lives*

between 2.5 and 26 hours10,11

L403524_Slim_Jim.indd 7 7/20/10 11:54 AM

FROVA first for female migraine sufferers

Hours

0

5

10

15

20

25

30

FROVA

FROVA

®

Has a Long Elimina tion Half-life

of Approximately 26 Hours

9 9 26-HO u R H ALF -L iFE

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. 1st ed. 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. US Department of Health and Human Services, Office on Women’s Health. Migraine. http://www.womenshealth.gov/faq/migraine.pdf. Accessed June 29, 2010. 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. 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):1465-1472. 9. FROVA® [package insert].

Chadds Ford, PA: Endo Pharmaceuticals; 2007. 10.Physicians’ Desk Reference. 63rd ed. Montvale, NJ: Physicians’ Desk Reference Inc; 2008. 11. RELPAX® [package insert]. New York, NY: Pfizer Inc; 2008.

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FROVA first for female migraine sufferers

11

Tolerated in Clinical Trials

9

Important Safety Information

• 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.

Safe

T

y

profile

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L403524_Cover_PF.indd 1 7/20/10 12:33 PM

10

FROVA

®

Was Generally Well

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

Adverse event profile similar to that of placebo

L403524_Slim_Jim.indd 1 7/20/10 11:54 AM

MeNSTrUal MiGraiNe

Migraine attacks Can Be

and often recur

1-4

(7)

Safety

profile

FROVA first for female migraine sufferers

treat Migraines that

are long in Duration

and/or recur With

froVa

®

FROVA® is a registered trademark of Vernalis Development Limited.

© 2010 Endo Pharmaceuticals. All Rights Reserved. FR-0389/July 2010 www.FROVA.com 1-800-462-ENDO (3636)

ChADDs FORD, PENNsyLVANiA 19317

• 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

Indication

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.

Important Safety Information

• 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.

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M O N T H S M T W TH F S Period Migraine Menstrual Migraine Window S M T W TH F S

X X

X X X

X X

X X

X

Period Migraine Menstrual Migraine Window M O N T H Pure Menstrual Migraine (migraine during menstruation days –2 through +3)* Menstrually Related Migraine (migraine during menstruation days –2 through +3 and other times of the month)*

Menstrual Migraine without aura can be either

5

Menstrual Migraines 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 † Compared with migraines that occur at other

times of the month.

• Evidence suggests Menstrual

Migraines are strongly associated

with hormone changes that

naturally occur during a monthly

menstrual cycle

5,9

Migraines are generally predictable

Up to an Estimated 60% of the 21 Million

US Female Migraine Sufferers Experience

Migraines Around the Time of Their Period

and at Other Times of the Month

1-4

FROVA first for female migraine sufferers

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

*In at least 2 out of 3 menstrual cycles.

Indication

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.

Important Safety Information

• 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.

(9)

only

FROVA® is a registered trademark of Vernalis Development Limited.

© 2010 Endo Pharmaceuticals. All Rights Reserved. FR-0389A/July 2010 www.FROVA.com 1-800-462-ENDO (3636) ChADDs FORD, PENNsyLVANIA 19317

Do Your Patients Have Migraines

That Are Long in Duration

and/or Recur?

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 Migraine study II. Headache. 2001;41(7):646-657. 2. 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. 3. 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):185-193. 4. 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.

5. headache Classification subcommittee of the International headache society (Ihs). The international classification of headache disorders. Cephalalgia.

2004;24(suppl 1):8-160. 6. 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):302-308. 7. 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. 8. MacGregor EA, hackshaw A. Prevalence of migraine on each day of the natural menstrual cycle. Neurology. 2004;63(2):351-353. 9. 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. 10. 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.

“ 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

Migraine 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

Figure

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References

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