Thank you for visiting
TREXIMET.com

You are about to leave the TREXIMET® (sumatriptan/naproxen sodium) website and enter a website operated by an independent third party. The links to the third-party websites contained in TREXIMET.com are provided for your convenience. Pernix Therapeutics does not control the opinions or claims contained in any third-party website linked to TREXIMET.com. The policies and practices of third-party websites may differ from ours.

Would you like to leave TREXIMET.com?

Visit Patient Site
Treximet (sumatriptan/naproxen sodium) | Migraines are complex. Keep it simple.

Patients may pay as little as $25*1

*Some restrictions apply.

Get a savings card now!

Fast symptom control, lasting headache relief

Learn More

First-line therapy for your patients with inadequate acute migraine control

TREXIMET® is the only fixed-dose sumatriptan/naproxen combination designed to address distinct aspects of acute migraine.2,3

Choose TREXIMET® (sumatriptan/naproxen sodium) first for your patients because it provides:

  • Rapid-release RT Technology™, not available in generic sumatriptan tablets, which ensures rapid medication dispersion even during gastric stasis4,3
  • Superior efficacy vs. sumatriptan or naproxen alone across multiple measures2,3 including:
    • 2-hour pain freedom
    • 2- to 24- hour sustained pain freedom
    • Low 24-hour recurrence rate
  • Multiple copay support programs for commercially insured patients.

TREXIMET is a registered trademark of Pernix Ireland Limited. All other trademarks are property of their respective owners.

Designed for speed and duration

  • TREXIMET® has a distinct pharmacokinetic profile vs. its individual components5
  • Sumatriptan tablets formulated with RT Technology™ disintegrated and dispersed > 3X faster than non-RT sumatriptan tablets (9.5 vs 33.4 mins)6
  • More efficient absorption, even in patients with gastric stasis4

Clinical significance of these data not known.

Mean plasma concentrations obtained from a single-center, randomized, open-label, single-dose, 2-period crossover pharmacokinetic study in healthy volunteers (n=32) evaluating the pharmacokinetics following administration of a single TREXIMET® tablet, a single IMITREX 100-mg tablet (Tmax only shown); Tmax of naproxen sodium 550 mg is from a 3-way incomplete block study of 5 alternative formulations in healthy volunteers (n=40). All Tmax values are medians.

Sustained pain freedom

Superior 2- to 24-hour pain freedom vs. individual components2,5

P<0.05 TREXIMET® vs sumatriptan (comparison performed post hoc); P<0.001 TREXIMET® vs placebo (prespecified).

†P<0.01 TREXIMET® vs sumatriptan, naproxen sodium, and placebo; comparison performed post hoc.

Values corresponding to the 75% relative percentage shown for TREXIMET® are 63% and 67%, respectively, for patients receiving sumatriptan or naproxen alone.

Study Design: Randomized, double-blind, single-attack, placebo-controlled, parallel-group studies conducted among 1441 (Study 1) and 1470 (Study 2) patients diagnosed with migraine, evaluating the safety and efficacy of TREXIMET® in the acute treatment of moderate-to-severe migraine. Patients were randomized to receive TREXIMET®; sumatriptan 85 mg; naproxen sodium 500 mg; or placebo, to be used after onset of a migraine with moderate-to-severe pain. “Sustained pain-free” was defined as patients who were pain-free at 2 hours and remained pain-free at 24 hours, without any additional medication.

Prescribe with the confidence of coverage

Widely available on major commercial plans

  • Preferred or covered on formularies for 75% of commercially insured US lives7
  • Certain patients may pay as little as $25 when using the TREXIMET® Copay Program. Some limitations apply1

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
  • TREXIMET® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)].

INDICATION

TREXIMET® (sumatriptan and naproxen sodium) is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.

LIMITATIONS OF USE

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2%) were:

DRUG INTERACTIONS

You are encouraged to report negative side effects of taking TREXIMET® to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

To report adverse events, a product complaint, or for additional information about TREXIMET®, call Pernix Therapeutics at 1-877-745-3667.

Please see Full Prescribing Information, including Boxed WARNINGS, before prescribing TREXIMET®.

References: 1. Relayhealth transaction data, Dec 2015. 2. TREXIMET® Prescribing Information. Morristown, NJ: Pernix Therapeutics, LLC. May 2015. 3. Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007;297:1443-1454. 4. Walls C, Lewis A, Bullman J, et al. Pharmacokinetic profile of a new form of sumatriptan tablets in healthy volunteers. Curr Med Res Opin. 2004;20(6):803-809. 5. Haberer LJ, Walls CM, Lener SE, Taylor DR, McDonald SA. Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2010;50:357-373. 6. Data on file, Pernix Therapeutics, Inc.7.MMIT Formulary Database, Jan 2016

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings and Precautions (5.1)].
  • TREXIMET® is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4) Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see Warnings and Precautions (5.2)].

INDICATION

TREXIMET® (sumatriptan and naproxen sodium) is a combination of sumatriptan, a serotonin (5-HT) 1b/1d receptor agonist (triptan), and naproxen sodium, a non-steroidal anti-inflammatory drug, indicated for the acute treatment of migraine with or without aura in adults and pediatric patients 12 years of age and older.

LIMITATIONS OF USE

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2%) were:

DRUG INTERACTIONS

You are encouraged to report negative side effects of taking TREXIMET® to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

To report adverse events, a product complaint, or for additional information about TREXIMET®, call Pernix Therapeutics at 1-877-745-3667.

Please see Full Prescribing Information, including Boxed WARNINGS, before prescribing TREXIMET®.

References: 1. Relayhealth transaction data, Dec 2015. 2. TREXIMET® Prescribing Information. Morristown, NJ: Pernix Therapeutics, LLC. May 2015. 3. Brandes JL, Kudrow D, Stark SR, et al. Sumatriptan-naproxen for acute treatment of migraine: a randomized trial. JAMA. 2007;297:1443-1454. 4. Walls C, Lewis A, Bullman J, et al. Pharmacokinetic profile of a new form of sumatriptan tablets in healthy volunteers. Curr Med Res Opin. 2004;20(6):803-809. 5. Haberer LJ, Walls CM, Lener SE, Taylor DR, McDonald SA. Distinct pharmacokinetic profile and safety of a fixed-dose tablet of sumatriptan and naproxen sodium for the acute treatment of migraine. Headache. 2010;50:357-373. 6. Data on file, Pernix Therapeutics, Inc.7.MMIT Formulary Database, Jan 2016

Back to Top