Last reviewed · How we verify
Treximet
At a glance
| Generic name | Treximet |
|---|---|
| Also known as | Sumatriptan succinate 85mg/Naproxen Sodium 500mg, The brand name of sumatriptan/naproxen sodium is Treximet., Imitrex and Naproxen Sodium, Sumatriptan/Naproxen Sodium |
| Sponsor | Stephen H. Landy, M.D. |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS See full prescribing information for complete boxed warning. 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. ( 5.1 ) TREXIMET is contraindicated in the set
Common side effects
- Nausea
- Dizziness
- Somnolence
- Chest discomfort/chest pain
- Neck/throat/jaw pain/tightness/pressure
- Paresthesia
- Dyspepsia
- Dry mouth
- Hot flush
- Muscle tightness
Serious adverse events
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforation
- Arrhythmias
- Cerebrovascular Events
- Other Vasospasm Reactions
- Hepatotoxicity
- Anaphylactic Reactions
- Serious Skin Reactions
- Serotonin Syndrome
- Seizures
Key clinical trials
- i-NEED: NEw migrainE Drugs Database
- Use of the Combination of Sumatriptan and Naproxen in the Acute Treatment of Migraine: Real World Evidence Study
- Treatments of Migraine with Triptans in Individuals with Elevated Cardiovascular Risk and in Pregnant Women
- Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks (PHASE3)
- Treximet for Prevention of Post Traumatic Headache Associated With Cognitive Dysfunction (PHASE4)
- Does Treximet Improve Productivity and Patient Satisfaction Due to Sustained Response and Consistency of Response? (PHASE4)
- TREXIMA and RELPAX Gastric Scintigraphy Inside and Outside a Migraine (PHASE3)
- A Pharmacokinetic Study to Evaluate TREXIMET in Adolescents With Migraine and Healthy Subjects Administered at Three Doses. (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Treximet CI brief — competitive landscape report
- Treximet updates RSS · CI watch RSS
- Stephen H. Landy, M.D. portfolio CI