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TREXIMA · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TREXIMA tablet followed by IMITREX injection (4mg) | EXPERIMENTAL | TREXIMA™ (sumatriptan succinate / naproxen sodium) Tablet followed by IMITREX® (sumatriptan succinate) Injection 4mg administered using the IMITREX STATdose System® |
| TREXIMA tablet followed by IMITREX injection (6mg) | EXPERIMENTAL | TREXIMA tablet followed by IMITREX® (sumatriptan succinate) Injection 6mg administered using the IMITREX STATdose System® |
| IMITREX tablet (100mg) | ACTIVE_COMPARATOR | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
| Name | Type | Description |
|---|---|---|
| TREXIMA™ | DRUG | sumatriptan succinate / naproxen sodium tablet |
| IMITREX® (4mg) | DRUG | sumatriptan succinate injection (4mg) administered using the IMITREX STATdose System® |
| IMITREX® (6mg) | DRUG | sumatriptan succinate injection (6mg) administered using the IMITREX STATdose System® |
| IMITREX Tablet 100mg | DRUG | IMITREX 100mg tablet followed 2 hours later by a second IMITREX 100mg tablet |
Inclusion Criteria: * Healthy adult males and females between 18 and 55 years of age, inclusive. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, laboratory studies and other tests. ...
TREXIMA is an investigational small molecule being developed for migraine disorders. It is a combination tablet containing sumatriptan succinate and naproxen sodium, intended for the treatment of migraine. As of the available data, TREXIMA is in Phase 1 clinical development and has not been approved by regulatory authorities.
TREXIMA is a combination of sumatriptan succinate and naproxen sodium. Sumatriptan is a serotonin receptor agonist that targets 5-HT1B and 5-HT1D receptors to constrict cranial vessels and inhibit pain pathways, while naproxen is a nonsteroidal anti-inflammatory drug that reduces inflammation. Together, they address migraine symptoms through complementary mechanisms.
TREXIMA is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical research on this combination therapy for migraine disorders.
TREXIMA is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The Phase 1 trial has been completed, and the drug remains under clinical investigation for migraine disorders.
TREXIMA has one completed Phase 1 clinical trial, registered as NCT00875784. This was an open-label, randomized, 3-period crossover study conducted in the United States with 30 participants. The trial evaluated the pharmacokinetics of TREXIMA compared to IMITREX (sumatriptan succinate) in healthy volunteers.
TREXIMA is not the same as IMITREX. TREXIMA is a combination tablet containing sumatriptan succinate and naproxen sodium, while IMITREX contains only sumatriptan succinate. A Phase 1 trial compared the pharmacokinetics of TREXIMA to IMITREX to assess how the combination formulation performs relative to the single-agent product.