Treximet (Sumatriptan Succinate / Naproxen Sodium) - Summary

TREXIMET SUMMARY

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.

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NEWS HIGHLIGHTS

Published Studies Related to Treximet (Sumatriptan / Naproxen)

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.

Two double-blind, multicenter, randomized, placebo-controlled, single-dose studies of sumatriptan/naproxen sodium in the acute treatment of migraine: function, productivity, and satisfaction outcomes. [2007.06.07]
OBJECTIVE: To describe return to normal function, productivity, and satisfaction of patients with moderate or severe migraine attacks treated with combined sumatriptan/naproxen sodium, sumatriptan alone, naproxen sodium alone, or placebo... CONCLUSIONS: Treatment with sumatriptan/naproxen sodium allowed significantly more subjects to return to normal or mildly impaired functioning more quickly, and sumatriptan/naproxen sodium patients were significantly more satisfied with their treatment compared with other treatment groups. Overall productivity loss was significantly reduced following use of sumatriptan/naproxen sodium.

Sumatriptan/naproxen sodium combination for the treatment of migraine. [2008.09]
Sumatriptan 85 mg with naproxen sodium 500 mg, a combination tablet for the acute treatment of migraine, is approved in the USA...

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Clinical Trials Related to Treximet (Sumatriptan / Naproxen)

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.

A Study to Determine the Effect of Sumatriptan and Naproxen Sodium Combination Tablet, Sumatriptan Tablet, and Naproxen Sodium Tablet on Blood Pressure When Treating Migraine Headaches That Occur During a 6-Month Period [Not yet recruiting]
The purpose of this study is to test the effect on blood pressure of sumatriptan and naproxen sodium combination tablets, tablets containing only sumatriptan, and tablets containing only naproxen sodium when these drugs are taken to treat migraine headaches that occur during a 6-month period.

Migraine Study in Adolescent Patients [Recruiting]
This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

Efficacy of Sumatriptan With Naprosyn in Migraine With Aura [Not yet recruiting]
This is a double-blinded placebo study, examining the efficacy of Sumatriptan with Naprosyn in the treatment of migraine with aura.

Inflammatory Markers in Migraine - Ictally and Interictally [Recruiting]
This study will measure two types of markers, adipokines and cytokines during an acute migraine attack. Adipokines have not previously been studied in this manner. Measurements of these markers in treated and untreated patients during an acute migraine attack ang again at a pain free interval may lead to increased understanding of the pathway to neurologic inflammation giving rise to migraine.

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