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sumatriptan/ naproxen · 1 trial · 1 indication
Pain-free was defined as a headache severity of no pain (grade 0) at 2 hours post-treatment in subjects who have not used rescue medication prior to or at the time of the assessment. Sustained pain-free response was defined as pain-free at 2 hours post-treatment through 24 hours post-treatment without rescue medicine.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | - |
| Treximet | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| sumatriptan succinate / naproxen sodium | DRUG | sumatriptan 85mg / naproxen sodium 500mg |
| Placebo | DRUG | Placebo to match Treximet tablets |
Inclusion Criteria: * At least a 6 month history of probably migraine (6 migraine attacks per month) * Males and women of childbearing potential on a adequate contraception. Exclusion Criteria: * Physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use...
Sumatriptan/naproxen is used for the acute treatment of migraine, including migraine without aura and menstrual migraine. It is a small molecule combination therapy being developed by GSK plc for neurology indications. The drug is intended to relieve migraine symptoms and is currently in Phase 3 clinical development.
Sumatriptan/naproxen combines a triptan and an NSAID. Sumatriptan targets serotonin receptors to constrict cranial vessels, while naproxen reduces inflammation. This dual mechanism addresses both vascular and inflammatory components of migraine. The drug is being studied for its efficacy in treating migraine attacks.
Sumatriptan/naproxen is developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for the acute treatment of migraine.
Sumatriptan/naproxen is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trials are completed, and the data will support potential regulatory submissions for migraine treatment.
Sumatriptan/naproxen has completed six Phase 3 trials, including NCT00329355 for menstrual migraine, NCT00329459 for menstrual migraine with dysmenorrhea, NCT00387881 for probable migraine, and NCT00963937 for migraine in children and adolescents. These trials enrolled a total of 2,431 participants.
Yes, sumatriptan/naproxen is the same as Treximet, which was formerly known as TREXIMA. The clinical trials referenced in the data use the names TREXIMET and TREXIMA interchangeably to describe this combination therapy for migraine treatment.