New Drug Review: Treximet (Sumatriptan-Naproxen) INDICATIONS 1 BACKGROUND CLINICAL PHARMACOLOGY 1

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1 Drug Use Research & Management Program DHS Division of Medical Assistance Programs, 500 Summer Street NE, E35; Salem, OR Phone Fax New Drug Review: Treximet (Sumatriptan-Naproxen) INDICATIONS 1 The FDA has approved sumatriptan-naproxen (Treximet ) for the acute treatment of migraine attacks with or without aura in adults. It has not been approved for the prophylactic therapy in migraine or for use in the management of hemiplegic or basilar migraine. BACKGROUND Treximet combines the HT 1 agonist sumatriptan with the nonsteroidal anti-inflammatory drug (NSAID) naproxen sodium into one product for the acute treatment of migraine headache. Presently, guidelines for the treatment of migraine do not address the use of combination products or products in combination for migraine management. 2 The American Academy of Neurology s (AAN) evidence-based guidelines recommend linking the intensity of care for migraine headaches with the level of disability and symptoms, which is called stratified care. Accordingly, the guidelines recommend using of triptans as first-line therapy for the acute treatment of migraine in those whose symptoms are moderate to severe and in those who have mild to moderate migraine headaches that respond poorly to NSAIDs or other simple analgesics; for example, caffeine combinations. AAN guidelines recommend the use of NSAIDs as first-line therapy for the treatment of mild to moderate migraine headaches, with grade A evidence given for the use of ibuprofen, naproxen sodium, and aspirin. 2 Brandes et al. and Smith et al. hypothesize greater efficacy would be achieved in acute therapy for migraine by using both a triptan and an NSAID, as the two medications would target different mechanisms of the pathogenic processes thought to underlie migraine attack. Migraine symptoms arise from abnormal, intermittent peripheral and central nervous system excitability, with activation of the trigeminal nerve. The triptan would prevent the release of inflammatory mediators from nerve endings, block nociceptive transmission in the trigeminal system of the brainstem, and reduce vasodilation, while the NSAID would block prostaglandin production and could moderate meningeal inflammation. In theory, the combination product would enhance acute relief and prolong therapeutic response. 3, 4 However, this has not been proven in clinical studies. Triptans, and therefore Treximet, are only intended for the acute, intermittent treatment of migraine and not for prophylaxis or continuous use. The AAN recommends considering preventive treatment for those whose migraines substantially impacts their lives and have been unresponsive to acute treatment or for those whose migraines occur with such frequency that relying on acute care medications would increase the potential for rebound, or medication-overuse, headaches. Consequently, the guidelines state many experts limit acute therapy to two headache days per week on a regular basis. 2 CLINICAL PHARMACOLOGY 1 Treximet contains sumatriptan succinate and naproxen sodium, which contribute to migraine headache relief through different mechanisms of action. Sumatriptan is a selective 5-hydroxytryptamine (5-HT) agonist that binds with high affinity to 5-HT and 5-HT receptors. Sumatriptan acts by mediating 1B 1D vasoconstriction of the human basilar artery and dura mater vasculature, which correlates with migraine

2 headache relief. Animal studies show sumatriptan also activates 5-HT receptors on peripheral terminals 1 of the trigeminal nerve innervating cranial blood vessels, which may contribute to its action in humans. Naproxen sodium is an NSAID an analgesic that inhibits the synthesis of inflammatory mediators. Naproxen s mechanism of action is incompletely understood but may be related to inhibiting prostaglandin synthetase. CLINICAL EFFICACY FDA approval of Treximet was based on two identically designed, randomized, double-blind, placebocontrolled trials. Both trials were published in one paper by Brandes et al. 3 The studies were conducted in 118 US clinical centers and enrolled 1461 (study1) and 1495 (study 2) subjects diagnosed as having migraine. Included in the studies were men and nonpregnant, nonlactating women between the ages of 18 and 65 years who had a 6-month history of migraine with or without aura, an average of 2 to 6 moderate or severe migraine episodes monthly during the 3 months prior to screening, and could distinguish migraine attacks from other headache types. Excluded were those who had >6 migraine attacks monthly or nonmigraine headache 15 days per month within months of screening; uncontrolled hypertension; cardiovascular or cerebrovascular disease; history of cardiac arrhythmias requiring medication; electrocardiogram abnormalities; basilar or hemiplegic migraine; recent use of ergot-derived or -like drugs, monoamine oxidase inhibitors, or St John s Wort; or regular use of anticoagulants or NSAIDs, except aspirin for CVD prophylaxis. The majority of patients were women and Caucasian. Subjects were randomized 1:1:1:1 to receive a single tablet of sumatriptan 85mg/naproxen 500 mg, sumatriptan 85 mg, naproxen sodium 500 mg, or placebo. Following were the six primary efficacy endpoints, with the first four comparing sumatriptan-naproxen to placebo and the fifth and sixth comparing sumatriptan-naproxen to sumatriptan and to naproxen: (1) percent patients who had headache relief 2 hours after dosing, with relief defined as moderate or severe pain reduced to mild or no pain without use of rescue medication (2) percent patients who had absence of photophobia (3) percent patients who had absence of phonophobia (4) percent patients who had absence of nausea (5 and 6) percent patients who had sustained pain-free response, defined as moderate or severe pain reduced to no pain from 2 through 24 hours after dosing with no use of rescue medication Subjects were instructed to treat a migraine attack with study medication when the migraine severity was moderate to severe. Patients recorded on diary cards details of the migraine treated with study medication and use of concomitant medication. Patients were allowed to use rescue medication beginning 2 hours after dosing with study medication. Patients rated migraine pain severity 0 (none), 1 (mild), 2 (moderate), or 3 (severe) immediately before dosing, every half-hour up to 2 hours post-dosing, and then hourly from 2 to 24 hours. Patients were to indicate whether they had vomited at any time within 24-hours post-dose. Primary efficacy analysis was performed for the intent-to-treat population, defined as randomized subjects who took study medication, recorded moderate or severe baseline pain, and had at least one postbaseline efficacy evaluation. Primary efficacy data were as follows:

3 Efficacy population no. Sumatriptan-naproxen Placebo P value NNT Study Study Headache relief at 2 h (%) Study < Study < Absence of nausea at 2 h (%) Study Study NS N/A 3. Absence of photophobia at 2 h (%) Study < Study < Absence of phonophobia at 2 h (%) Study < Study < Sumatriptannaproxen Sumatriptan Naproxen P value Sum-nap v. sumatriptan NNT P value Sum-nap v. naproxen Efficacy population no. Study Study /6. Sustained pain-free (%) Study < < Study < < The FDA approved Treximet based on the superiority of Treximet over its individual components for sustained pain-free response. Additionally, Treximet was expected to be no worse than its individual components in treating the associated symptoms of migraine: nausea, photophobia, and phonophobia. Treximet met this criteria. 4 However, post-hoc analysis, many without adjustments for multiple comparisons, reveals Treximet s superiority over sumatriptan to be modest for the first four primary measures (table below). There s no superiority of Treximet over sumatriptan for relief of headache at 2 hours for patients with severe headache and results are mixed for those with moderate headache. 3 Also, the FDA clinical review says statistical significance for the secondary endpoint symptom-free at 2 hours for Treximet versus placebo was not reached (results not published). 4 NNT

4 Efficacy population no. Sumatriptan-naproxen Sumatriptan P value NNT Study Study Pain free at 2 h (%) Study * 11 Study <.03* 14 Headache relief at 2 h (%) Study Study Relief of moderate headache at 2 h (%) Study * 9 Study NS* NA Relief of severe headache at 2 h (%) Study NS* NA Study NS* NA Absence of nausea at 2 h (%) Study NS NA Study NS NA Absence of photophobia at 2 h (%) Study Study NS NA Absence of phonophobia at 2 h (%) Study Study NS NA *Not adjusted for multiple comparisons. Other limitations of the studies were as follows: (1) The first four primary endpoints were versus placebo, rather than sumatriptan, a more logical comparator. (2) Statistical analysis could have included confidence intervals so that the level of precision of the results would be readily apparent. 5 (3) The study used percentage of patients with headache relief at 2 h as a primary endpoint rather than the recommended percentage of patients pain-free at 2 h. The International Headache Society (IHS) points out that the headache relief endpoint treats a change from moderate pain to mild pain the same as severe pain to no pain and that patients expect treatment to leave them pain free. Therefore, the pain free endpoint is more clinically significant. 5 (4) The studies participants were required to only have a headache history of 6 months or more. The IHS recommends 1 year so that headache types that may mimic migraine can be excluded as a diagnosis. 5 (5) Only one migraine attack per patient was evaluated; therefore, no data are available on consistency of response to Treximet. 5 (6) The studies did not clearly prove Treximet to have a positive effect on nausea and vomiting. (7) The primary endpoint upon which the FDA approved Treximet, sustained pain-free, was defined as moderate or severe pain at treatment reduced to no pain from 2 hours through 24 hours after dosing with no use of rescue medication, rather than 48 hours as recommended by the IHS. 5 (8) The optimal dosing for the sumatriptan and naproxen components of the combination product was not determined.

5 (9) The advantages of taking a combination product versus taking sumatriptan and naproxen separately are unclear. A study by Smith et al., which included three of the same researchers conducting the Treximet trials, compared placebo, naproxen 500 mg, and sumatriptan 50 mg with sumatriptan 50 mg taken with naproxen 500 mg. Patients were randomized 1:1:1:1 and a total of 972 patients were treated. The primary endpoint was 24-hour sustained pain relief, defined as moderate or severe pain reduced to mild or no pain from 2 through 24 hours after dosing with no use of rescue medication. The percentages of patients with sustained pain relief were 46% for the combination, 29% for sumatriptan, 25% for naproxen, and 17% for placebo (p<0.001). Outcomes for the secondary endpoint 24-hour sustained painfree were 25% for the combination, 11% for sumatriptan, 12% for naproxen, and 5% for placebo (p 0.01). 6 Ideally, the Treximet study would have presented data comparing Treximet with sumatriptan, rather than placebo, for all primary efficacy endpoints. Because it did not, data is lacking on how Treximet compares with sumatriptan in resolving pain and other important migraine symptoms. Post-hoc analysis suggests Treximet may inconsistently outperform sumatriptan for relief or resolution of pain and would perform no better than sumatriptan for the relief of other symptoms. The study did compare Treximet with sumatriptan for the primary endpoint percent patients who had sustained pain-free response, but this measure was not ideal in that it was carried out for only 24 hours, rather than the recommended 48 hours. Dose comparison studies and studies comparing Treximet to sumatriptan and naproxen taken concurrently also would be of interest. Data from the Smith et al. trial of sumatriptan plus naproxen suggests the products taken separately but concurrently would perform as well as Treximet. DRUG SAFETY AND ADVERSE EFFECTS General Summary 1 The adverse events for Treximet reported in the product information concern only those for Treximet itself and not its components. Therefore, they are based on the relatively small number of patients in the two clinical trials in which patients only took one dose of Treximet. These trials exclude patients with uncontrolled hypertension, confirmed or suspected cardiovascular or cerebrovascular disease, history of cardiac arrhythmias requiring medication, and abnormal EKGs. Therefore, frequency of adverse events reported likely does not represent the frequency of adverse events in clinical practice. Adverse events occurring at a frequency 2 % for Treximet and greater than placebo were nervous system disorders (dizziness, somnolence, paresthesia), gastrointestinal disorders (nausea, dyspepsia, dry mouth), pain and other pressure sensations (chest discomfort or chest pain; neck or jaw or throat pain, tightness, or pressure). None of these symptoms taken individually occurred at a frequency greater than 4%. Treximet requires a patient medication guide and carries a black box warning with regard to use in patients with cardiovascular disease (CVD) or risk factors for CVD and the risk of gastrointestinal ulceration, bleeding, and perforation. Also, the list of contraindications, precautions, and warnings for Treximet is quite lengthy as it combines all those for both sumatriptan and naproxen. For example, contraindications alone include use in those with cardiac, cerebrovascular, or peripheral vascular disease, uncontrolled hypertension, hemiplegic or basilar migraine, hepatic impairment, aspirin or NSAIDinduced syndrome of asthma, rhinitis, and nasal polyps or hypotension. Unanswered Safety Questions At least three unanswered safety concerns arise with Treximet: (1) How will all of contraindications, warnings, and precautions associated with Treximet be managed in clinical practice? (2) Are any of the adverse effects of sumatriptan and naproxen additive in combination, in particular coronary artery vasoconstriction and increases in blood pressure? (3) How safe is Treximet with chronic, intermittent use?

6 DOSAGE AND ADMINISTRATION 1 Treximet is a fixed-dose combination tablet that contains 119 mg of sumatriptan succinate, which is equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. These doses are within the approved dosage range for sumatriptan (25 to 100 mg) and naproxen sodium (220 to 825 mg). Treximet s sumatriptan dose is therefore higher than the lowest effective dose, thus the product information states the benefits of a higher dose of sumatriptan should be weighed against the potential risks of adverse events. The recommended dose is 1 tablet with or without food. No more than 2 Treximet tablets should be taken in 24 hours. Doses should be at least 2 hours apart. Neither the efficacy of taking a second dose nor the safety of treating an average of more than 5 migraine headaches in a 30-day period has been established. Tablets should not be split, crushed, or chewed. Treximet is contraindicated in patients with hepatic impairment and is not recommended in patients with creatinine clearance <30 ml/min. Treximet is supplied in a packaged container of 9 tablets. CONCLUSIONS AND RECOMMENDATIONS Treximet is more effective than placebo and may only be marginally more effective than sumatriptan monotherapy, depending on the endpoint evaluated. Post-hoc analyses show Treximet has no superiority over sumatriptan for relief of headache at 2 hours for patients with severe headache and results are mixed for those with moderate headache. Additionally, Treximet did not separate from placebo for the secondary endpoint symptom-free at 2 hours. Results also are mixed for absence of photophobia and phonophobia. In one study, Treximet did not perform better than placebo for absence of nausea, a primary endpoint. 3 Rare but serious adverse events can arise from taking sumatriptan or naproxen alone. Combining them in one product may increase the potential for serious adverse effects, particularly when the combination is used when monotherapy would suffice. Long-term safety data with chronic, intermittent use of Treximet compared with monotherapy would be useful. The potential for coronary artery vasoconstriction and increased blood pressure are of particular concern. 4 At a minimum, Treximet should have a quantity limit similar to that set for other triptans. Therefore, it is recommended the quantity limit be set to 9 tablets within a 30-day period, which is enough to treat 4 headaches using a maximum of 2 doses per headache. REFERENCES 1. Treximet prescribing information. Research Triangle Park, NC: GlaxoSmithKline; 2009 Dec. 2. Silberstein SD. Practice parameter: Evidence-based guidelines for migraine headache (an evidence-based review): Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2000; 55: Brandes JL, Kudrow D, Stark SR et al. Sumatriptan-Naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007; 297(13): Food and Drug Administration Center for Drug Evaluation and Research. Application number: medical review(s). (accessed 2010 Feb. 26) 5. Tfelt-Hansen, Block G, Dahlöf C et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalagia. 2000; 20: Smith TR, Sunshine A, Stark SR et al. Sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2005; 45:

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