SUMATRIPTAN AND NAPROXEN SODIUM (naproxen sodium)
Sumatriptan and naproxen sodium is a combination medication indicated for the acute treatment of migraine with or without aura. It is approved for use in adults and pediatric patients aged 12 years and older. The therapy is intended only for the treatment of active migraine attacks and is not indicated for the prevention of migraines or the treatment of cluster headaches.
How SUMATRIPTAN AND NAPROXEN SODIUM Works
Sumatriptan acts as an agonist at 5-HT 1B/1D receptors on intracranial blood vessels and sensory nerves, resulting in vessel constriction and the inhibition of neuropeptide release. Naproxen sodium functions by inhibiting cyclooxygenase enzymes, which reduces the production of prostaglandins that mediate inflammation and sensitize nerves to pain. These combined mechanisms provide analgesic, anti-inflammatory, and antipyretic properties to address migraine symptoms.
Details
- Status
- Prescription
- First Approved
- 2018-02-15
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
SUMATRIPTAN AND NAPROXEN SODIUM Approval History
What SUMATRIPTAN AND NAPROXEN SODIUM Treats
2 indicationsSUMATRIPTAN AND NAPROXEN SODIUM is approved for 2 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Migraine
- Cluster Headache
SUMATRIPTAN AND NAPROXEN SODIUM Boxed 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)] . Sumatriptan and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG)...
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)] . Sumatriptan and naproxen sodium tablets are 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)] . 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) Sumatriptan and naproxen sodium tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (4, 5.1) 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. (5.2)
SUMATRIPTAN AND NAPROXEN SODIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04145518 MCUP | EH19-040 R01HD098193-01A1 | Ph 4 | completed | Mechanistic Characterization of Uterine Pain |
| NCT04015596 results posted | 2019P000623 | Ph 4 | terminated | Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS |
| NCT05761574 | CCSPAA005199 CCSPAA005199 | Ph 3 | completed | A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain |
| NCT05982392 | 2889 | Ph 2, Ph 3 | completed | Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain |
| NCT01107236 | ICP-109-201 | Ph 2 | completed | Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction |
| NCT03291418 | ATB-346-P2GIS | Ph 1, Ph 2 | completed | To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects |
| NCT00843024 results posted | 107979 | Ph 3 | completed | Migraine Study in Adolescent Patients |
| NCT01090050 results posted | 112839 | Ph 4 | completed | Treximet in the Treatment of Chronic Migraine |
| NCT01300546 results posted | 114933 | Ph 4 | completed | Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine |
| NCT00692016 Keifer | 13080 | Ph 1 | completed | Fast & Fed Pharmacokinetic (PK) Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SUMATRIPTAN AND NAPROXEN SODIUM FDA Label Details
Indications & Usage
SUMATRIPTAN AND NAPROXEN SODIUM is indicated for the treatment of Migraine; Cluster Headache.
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 ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.