Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TREXIMET · 2 trials · 2 indications
SPF 2-24 hours is defined for all participants as having no pain at 2 hours post-dose and without the return of any pain or the use of any rescue medication (any medication taken after the first dose of study medication for any migraine pain or symptoms) from 2-24 hours.
The number of participants with a drug-related adverse event (AE). Frequency threshold for reporting a drug-related AE: \>=2% participants recorded as having at least one occurrence of a reported drug-related AE.
| Arm | Type | Description |
|---|---|---|
| TPB | OTHER | TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3) |
| TBP | OTHER | TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3) |
| BTP | OTHER | BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3) |
| BPT | OTHER | BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3) |
| PTB | OTHER | placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3) |
| PBT | OTHER | placebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3) |
| Active Drug | OTHER | Combination Tablet of Treximet (sumatriptan/naproxen sodium) |
| Name | Type | Description |
|---|---|---|
| TREXIMET® | DRUG | Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg) |
| Butalbital-containing Combination Medications (BCM) | DRUG | butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\] |
| placebo | DRUG | placebo |
| Combination Tablet of Treximet (sumatriptan/naproxen sodium) | DRUG | Combination Tablet of Treximet(sumatriptan/naproxen sodium) |
Inclusion Criteria: * Males and females aged 18 to 65 years. Female subjects are eligible for participation if they are either of non-childbearing potential (not capable of becoming pregnant) OR of childbearing potential having a negative urine pregnancy test at screening, and using contraception i...
TREXIMET is used for the acute treatment of migraine disorders in adults and has also been studied for migraine in adolescents. It is a small molecule combination therapy developed in the neurology therapeutic area. Its clinical program includes two completed Phase 3 trials with a combined enrollment of 1,031 participants.
TREXIMET is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the TREXIMET clinical development program in migraine disorders, including the completed Phase 3 trials NCT00573170 and NCT00488514.
TREXIMET has been studied in Phase 3 clinical development for migraine disorders. Two Phase 3 trials have been completed, and no trials are currently active. The program enrolled 1,031 participants across randomized, double-blind, controlled studies.
TREXIMET has been evaluated in two completed Phase 3 trials. NCT00573170 compared TREXIMET with butalbital-containing combination medications for acute migraine treatment in adults, enrolling 375 participants in the United States. NCT00488514 assessed long-term safety of sumatriptan/naproxen sodium for migraine in adolescents, enrolling 656 participants.