Migraine Headache Relief

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MAXALT® (rizatriptan benzoate) and MAXALT-MLT® (rizatriptan benzoate)
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    • 2-hour Pain Relief
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Learn more about migraine and migraine diagnosis. Click Here

For some patients with migraine... MAXALT-MLT Delivered Effective Pain Relief at 2 hours

For many patients with migraine

MAXALT Delivered Effective Pain Relief at 2 Hours

In pivotal clinical studies ...

Patients Improving From Moderate or Severe to Mild or No Pain at 2 Hours %

60% to 63% of patients taking MAXALT 5 mg demonstrated pain relief at 2 hours: Study 022: 62% (n=458), placebo 35% (n=304); Study 029 (not shown): 63% (n=352), placebo 23% (n=80); Study 030: 60% (n=164), placebo 40% (n=159). Study 022: P<0.05 vs placebo; Study 029: P<0.01 vs placebo; Study 030: P<0.001 vs placebo.1,3,4

For many patients with menstrual migraine ...

MAXALT Delivered Effective Pain Relief at 2 Hours

In clinical studies of menstrual migraine, the first to use ICHD-II proposed criteriaa,5 ...

Patients Improving From Moderate or Severe to Mild or No Pain at 2 Hours, %
a
 
 
 
Results from multicenter, randomized, double-blind, placebo-controlled studies among 802 patients with moderate or severe pure menstrual migraine without aura or menstrually related migraine without aura, according to International Headache Society (IHS) criteria. Patients who treated a mild headache were included (MM1: 7 taking MAXALT and 5 taking placebo; MM2: 7 taking MAXALT and 4 taking placebo).5,6
  • The safety profile for MAXALT in the menstrual migraine studies5 was consistent with the safety profile previously reported for MAXALT in clinical studies.
  • MAXALT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether MAXALT is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXALT is administered to women who are breast-feeding.

For many patients with migraine ...

MAXALT — Taken When Migraine Headache Pain Was Moderate —
Delivered Effective Relief at 2 Hours

 
In a prespecified subgroup analysis of 3 studies of patients treated with MAXALT 10-mg tablets ...
  Patients Improving From Moderate to Mild or No Pain at 2 Hours,%

75% to 81% of patients demonstrated pain relief at 2 hours when migraine headache pain was moderatea,7

 

a
P values are not shown because these studies were not powered to show treatment differences within the subgroup.



 

 

 

 

66% to 74% of patients taking MAXALT 5 mg demonstrated pain relief at
2 hours. Study 022: 66% (n=298), placebo 38% (n=201); Study 030: 74%
(n=72), placebo 51% (n=75).7

For many patients with migraine ...

MAXALT — Taken When Migraine Headache Pain Was Severe —
Delivered Effective Relief at 2 Hours

 
In a prespecified subgroup analysis of 3 studies of patients treated with MAXALT 10-mg tablets ...
Patients Improving From Severe to Mild or No Pain at 2 Hours, %

59% to 64% of patients demonstrated pain relief at 2 hours when migraine headache pain was severea,7

 

a
P values are not shown because these studies were not powered to show treatment differences within the subgroup.

 

 

 

 

50% to 53% of patients taking MAXALT 5 mg demonstrated pain relief at
2 hours. Study 022: 53% (n=151), placebo 27% (n=94); Study 030: 50%
(n=92), placebo 31% (n=84).7

Study Designs: MAXALT-MLT
 

Study 039: A multicenter, randomized, double-blind, placebo-controlled clinical trial examining the safety, tolerability, and efficacy of MAXALT-MLT 10 mg and MAXALT-MLT 5 mg for the treatment of acute migraine and migraine recurrence in patients with moderate to severe headache.

Study 049: A multicenter, randomized, triple-blind, placebo-controlled clinical trial examining the efficacy, safety, and tolerability of MAXALT-MLT 10 mg and MAXALT-MLT 5 mg in patients with moderate to severe headache.


Study Designs: MAXALT
 

Study 022: A multicenter, randomized, double-blind, placebo-controlled clinical trial examining the safety, tolerability, and efficacy of MAXALT 10 mg and MAXALT 5 mg for the treatment of acute migraine and migraine recurrence in patients with moderate to severe headache.a

Study 025: A multicenter, randomized, triple-blind, placebo-controlled clinical trial examining the efficacy, safety, and tolerability of MAXALT 10-mg tablets in patients with moderate to severe headache.a

Study 029: A multicenter, randomized, placebo-controlled, parallel-group, double-blind outpatient study examining the safety, efficacy, and tolerability of single oral doses of MAXALT 5 mg or active comparator for the treatment of acute migraine in patients with moderate to severe headache.

Study 030: A multicenter, randomized, double-blind, placebo-controlled, parallel-group outpatient study examining the safety, tolerability, and efficacy of single oral doses of MAXALT 5 mg, MAXALT 10 mg, or active comparator for the treatment of acute migraine in patients with moderate to severe headache.a

Studies MM1 and MM2: Two multicenter, randomized, double-blind, placebo-controlled studies using MAXALT 10-mg tablets with patients with moderate or severe menstrual migraine without aura or menstrually related migraine without aura, according to IHS criteria. The first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II).

a The moderate and severe charts depicting 2-hour relief by headache severity were based on a prespecified subgroup analysis of Studies 022, 025, and 030. Patients treated with MAXALT 10-mg tablets when migraine pain was moderate or severe.

 

In clinical studies ...
66% to 74% of patients taking MAXALT-MLT 10 mg demonstrated pain relief at 2 hours

Patients Improving From Moderate or Severe to MIld or No Pain at 2 Hours, %

59% to 66% of patients taking MAXALT-MLT 5 mg demonstrated pain relief at 2 hours: Study 039: 66% (n=100), placebo 47% (n=98); Study 049: 59% (n=181), placebo 28% (n=180). P<0.01 compared with placebo.

2-Hour Data

In pivotal clinical studies ...
67% to 77% of patients taking MAXALT
10-mg tablets demonstrated pain relief at 2 hours1–3

Menstrual Migrane
When Pain Was Moderate
When Pain Was Severe
Click to view study designs.
 

Phenylketonurics: MAXALT-MLT contains phenylalanine.

MAXALT is indicated for the acute treatment of migraine attacks with or without aura in adults. MAXALT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine. Safety and effectiveness of MAXALT have not been established for cluster headache, which is present in an older, predominantly male population.

Selected Safety Information

MAXALT 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. Because MAXALT may increase blood pressure, it should not be given to patients with uncontrolled hypertension. MAXALT should not be used within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide. MAXALT should not be administered to patients with hemiplegic or basilar migraine. Concurrent administration of MAO inhibitors or use of rizatriptan within 2 weeks of discontinuation of MAO inhibitor therapy is contraindicated. MAXALT is contraindicated in patients who are hypersensitive to rizatriptan or any of its inactive ingredients.

MAXALT should only be used where a clear diagnosis of migraine has been established.

MAXALT can cause coronary vasospasm and should not be given to patients with documented ischemic or vasospastic coronary artery disease (CAD). It is strongly recommended that MAXALT not be given to patients in whom unrecognized CAD is predicted by the presence of risk factors unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of CAD and ischemic myocardial disease or other significant underlying cardiovascular disease. For patients with these risk factors who are determined to have a satisfactory cardiovascular evaluation, see WARNING section of the Prescribing Information.

Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following the administration of rizatriptan. Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of other 5-HT1 agonists. Considering the extent of use of 5-HT1 agonists in patients with migraine, the incidence of these events is extremely low.

Cases of life-threatening serotonin syndrome have been reported during combined use of selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) and triptans.

The most common adverse events include asthenia/fatigue, somnolence, pain/pressure sensations, and dizziness, and they appear to be dose related. Potentially important adverse events that have occurred in clinical practice and reported through postmarketing surveillance include myocardial ischemia, myocardial infarction, peripheral vascular ischemia, stroke, serotonin syndrome, seizure, dysgeusia, hypersensitivity reaction, anaphylaxis/anaphylactoid reaction, angioedema (eg, facial edema, tongue swelling, pharyngeal edema), wheezing, and toxic epidermal necrolysis.

Before prescribing MAXALT-MLT or MAXALT, please read the Prescribing Information.

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References:

  1. Teall J, Tuchman M, Cutler N, et al; on behalf of Rizatriptan 022 Study Group. Rizatriptan (MAXALT) for the acute treatment of migraine and migraine recurrence: a placebo-controlled, outpatient study. Headache. 1998;38:281–287.
  2. Kramer MS, Matzura-Wolfe D, Polis A, et al; and Rizatriptan Multiple Attack Study Group. A placebo-controlled crossover study of rizatriptan in the treatment of multiple migraine attacks. Neurology. 1998;51:773–781.
  3. Tfelt-Hansen P, Teall J, Rodriguez F, et al; on behalf of Rizatriptan 030 Study Group. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Headache. 1998;38:748–755.
  4. Lines C, Visser WH, Vandormael K, Reines SA; on behalf of Rizatriptan/Sumatriptan Comparison Study Group. Rizatriptan 5 mg versus sumatriptan 50 mg in the acute treatment of migraine. Headache.
    1997;37:319–320.
  5. Mannix LK, Loder E, Nett R, et al. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies. Cephalalgia. 2007;27:414–421.
  6. Headache Classification Subcommittee of the International Headache Society. The international classification of headache disorders: second edition. Cephalalgia. 2004;24(suppl 1):1–140.
  7. Data available on request from Merck & Co., Inc., Professional Services-DAP, WP1-27, PO Box 4, West Point, PA 19486-0004. Please specify information package 20753544(2)-MAX.

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20851534(1)-11/08-MAX
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Resources for MAXALT on Merck Product Services:

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Learn about special offers for your migraine patients. Click Here 5 mg, MAXALT tablet, NDC# 6-0266-12 5 mg, MAXALT-MLT, NDC# 6-3800-12 10 mg, MAXALT tablet, NDC# 6-0267-12 10 mg, MAXALT-MLT, NDC# 6-3801-12