TREXIMET may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS: Cardiovascular Effects).
TREXIMET contains a nonsteroidal anti-inflammatory drug (NSAID). NSAID-containing products cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS: Risk of Gastrointestinal Ulceration, Bleeding, and Perforation With Nonsteroidal Anti-inflammatory Drug Therapy).
TREXIMET contains sumatriptan (as the succinate), a selective 5-hydroxytryptamine1 (5-HT1) receptor subtype agonist, and naproxen sodium, a member of the arylacetic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs).
TREXIMET is indicated for the acute treatment of migraine attacks with or without aura in adults. Carefully consider the potential benefits and risks of TREXIMET and other treatment options when deciding to use TREXIMET.
TREXIMET is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of TREXIMET have not been established for cluster headache.
Published Studies Related to Treximet (Sumatriptan / Naproxen)
Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. [2011.05]
OBJECTIVE: To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea. BACKGROUND: Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed... CONCLUSION: A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea. (c) 2011 American Headache Society.
Pharmacokinetics and tolerability of sumatriptan after single-dose administration of a fixed-dose combination tablet of sumatriptan/naproxen sodium 85/500 mg followed two hours later by subcutaneous sumatriptan 4- or 6-mg injection: a randomized, open-label, three-period crossover study in healthy volunteers. [2010.06]
BACKGROUND: Rescue medication options that are consistent with the product labeling for sumatriptan/naproxen sodium (S/N) and that have been permitted in >or=1 clinical trial include the use of a second tablet of S/N, sumatriptan tablets (to a total daily dose of 200 mg), and naproxen sodium tablets (within the maximum limits recommended in the labeling). Sumatriptan subcutaneous (SC) injection might be especially useful as rescue medication mostly because of its rapid onset of activity. OBJECTIVE: The aim of this study was to assess the pharmacokinetics and tolerability of sumatriptan SC used as rescue medication after the administration of oral S/N for the treatment of migraine... CONCLUSIONS: Sumatriptan 4 and 6 mg SC administered 2 hours after an S/N tablet yielded sumatriptan exposure that did not exceed that of S100 + S100. Cmax with the S/N + S6 regimen was 1.26-fold higher than reference values. Both regimens were reasonably well tolerated. Randomized controlled trials are needed to test the efficacy and tolerability of these SC regimens. ClinicalTrials.gov identifier: NCT00875784.
Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled, crossover study. [2009.08]
Two identical randomized, placebo-controlled, crossover studies were conducted to evaluate consistency of response to sumatriptan/naproxen sodium 85/500 mg (S/NS) over four attacks in adults with migraine. Patients were instructed to treat within 1 h of pain onset while pain was mild... The incidences of any adverse event and of specific adverse events were low and generally similar between S/NS and placebo.
Fixed-dose sumatriptan and naproxen in poor responders to triptans with a short half-life. [2009.07]
OBJECTIVE: To evaluate efficacy and tolerability of a single, fixed-dose tablet of sumatriptan 85 mg/naproxen sodium 500 mg (sumatriptan/naproxen sodium) vs placebo in migraineurs who had discontinued treatment with a short-acting triptan because of poor response or intolerance. BACKGROUND: Triptan monotherapy is ineffective or poorly tolerated in 1 of 3 migraineurs and in 2 of 5 migraine attacks. In April, 2008, the Food and Drug Administration approved the combination therapy sumatriptan/naproxen sodium, developed specifically to target multiple migraine mechanisms. This combination product offers an alternative migraine therapy for patients who have reported poor response or intolerance to short-acting triptans... CONCLUSION: In migraineurs who reported poor response to a short-acting triptan, sumatriptan/naproxen sodium was generally well tolerated and significantly more effective than placebo in conferring initial, intermediate, and sustained efficacy for pain and migraine-associated symptoms of photophobia and phonophobia.
Multimechanistic (sumatriptan-naproxen) early intervention for the acute treatment of migraine. [2008.07.08]
BACKGROUND: Research suggests treating a migraine at the first sign of pain increases the likelihood of the best clinical outcome. OBJECTIVE: To investigate the efficacy and tolerability of a fixed-dose, single-tablet formulation of sumatriptan 85 mg, formulated with RT Technology, and naproxen sodium 500 mg (sumatriptan/naproxen) as early intervention acute therapy for migraine... CONCLUSION: The fixed-dose single-tablet formulation of sumatriptan/naproxen was effective and well tolerated in an early intervention paradigm for the acute treatment of migraine, including traditional and nontraditional symptoms.
Clinical Trials Related to Treximet (Sumatriptan / Naproxen)
Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? [Recruiting]
Researchers want to learn about work productivity after treatment of a migraine headache
with your usual migraine medication as compared to your work productivity after treatment
During this research subjects will take Treximet to treat 3 workday migraine attacks. For a
second part of the research subjects will take their usual prescribed medication for 3
workday migraine attacks. The subjects will complete questionnaires after treating each
Treximet in Acute Migraine Headache: Assessing Cognitive Function [Recruiting]
Migraine headache occurs frequently in women more than men and is associated with symptoms
not only of significant pain but also of symptoms typically including of photophobia,
phonophobia, nausea and vomiting. Many migraine patients report difficulty in cognition
from lack of concentration, difficulty in word finding or inability to remember. Many of
these cognitive symptoms seem to be independent of the pain intensity and may occur
completely separately from the headache pain but can be disabling. It is likely that the
frequency and importance of cognitive symptoms associated with migraine are underreported.
The Mental Efficacy Workload Test (MEWT) is a computerized battery that is designed to be an
efficient and accurate measure of cognition during migraine headache. Treximet is a new
migraine treatment recently FDA approved for the treatment for the relief of acute migraine
that may be effective for the cognitive symptoms for migraine patients who have a history of
cognitive dysfunction during a migraine headache. The primary efficacy parameter is to
evaluate the effectiveness of treatment with Treximet versus placebo in patients with acute
migraine headache measuring neuropsychological function using the MEWT during the migraine
and comparing that score with a prior MEWT score when the patient had no migraine symptoms.
A double blind, placebo-controlled, crossover study was chosen so that each patient may be
her or his own control.
It is the intent of this study to determine the type and intensity of cognitive dysfunction
associated with migraine headache and to what extent that Treximet may relieve the cognitive
dysfunction in a safe and effective manner.
Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction [Recruiting]
This study will evaluate the effectiveness of Treximet when taken for post traumatic
headache by measuring any change in the number of headache days or any change in a subject's
ability to think following treatment with study medication. Eligible subjects will complete
3 visits. Following Visit 1, subjects will treat with their usual medication and document
headache symptoms and therapy in a Headache Diary. After 30 days, subjects will return for
Visit 2 and be randomized (like the flip of a coin) to receive Treximet or matching placebo
to treat at the same time each day. Treximet will be provided to treat any headache that
occurs. Subjects will complete a daily Diary. After 30 days, subjects will exit the study
at Visit 3.
Treximet Early Intervention Adolescent Migraine [Recruiting]
The study involves approximately 105 adolescent (ages 12-17) subjects to be screened at 4
sites across the US. All subjects enrolled will treat up to 4 MILD migraines over a 6 month
period. They will be required to have three office visits during the six months. All
subjects will be randomized to either Treximet (85mg Imitrex/500mg Naproxen Sodium) or
Placebo (sugar-pill) in four of the five treatment arms with a 3 to 1 ratio. A fifth
treatment arm will treat all 4 migraines with active drug, Treximet. The hypothesis is that
Treximet will prove to be a safe and effective treatment for this population, that has so
few treatment for migraine. And Treximet will be superior over placebo for pain free
endpoints at 2 and 24 hours.
Treximet Migraine Brain Imaging Research Study [Recruiting]
We are looking for volunteers who suffer from acute migraine (<14 episodes per month) to
participate in a 2-visit brain imaging research study. The goal of the study is to observe
the effect of acute administration of Treximet during a migraine episode on the pain
pathways of the migraine brain. Visit 1 will consist of 1 hour, where participants will be
signing the informed consent form, completing questionnaires, meeting with the study
physician, and having QST (sensory testing to determine individual pain thresholds to a heat
stimulus) performed. Visit 2 will occur during a migraine episode. Volunteers will be
asked to contact the study team at the first onset of a migraine. Upon arrival at Visit 2,
individuals will be given an IV for blood draws. Once these the IV is in place, subjects
will enter the MRI and be asked to stay very still. Scanning will occur for about 20
minutes, and then subjects will be given a Treximet tablet to combat their migraine. More
scanning will follow Treximet administration. Some scans will have no stimulation, and
others will apply a heat stimulus that subjects will rate using a pain scale. Seven 5-mL
blood samples will be drawn throughout the duration of the MRI session. Both Visit 1 and
Visit 2 will be compensated.
Reports of Suspected Treximet (Sumatriptan / Naproxen) Side Effects
Drug Ineffective (8),
Product Quality Issue (7),
Feeling Abnormal (6),
Chest Discomfort (4),
Sensation of Heaviness (4),
Asthma (3), more >>
Page last updated: 2011-12-09