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Also known as Sumatriptan, Sumatriptan Succinate
sumatriptan/naproxen · 8 trials · 3 indications
Pain relief was defined as at least a 2-grade reduction in pain intensity on a 5-grade scale in participants who had not used headache rescue medication before assessment. A pain intensity score of 5 was assigned for all subsequent assessments if a participant took rescue medication (a single oral dose for the treatment of migraine pain or associated symptoms). The 5-grade scale is a participant's self-rating scale to assess the pain intensity of a migraine with the following scores: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
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.
Headache relief rate was the percentage of participants who showed effectiveness 60 minutes post dose (migraine) or 30 minutes post dose (cluster headache). Data for participants with percentage effectiveness along with 95% confidence interval has been presented.
| Arm | Type | Description |
|---|---|---|
| Sumatriptan 25 mg | ACTIVE_COMPARATOR | - |
| Sumatriptan 50 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Sumatriptan and Naproxen 1 | EXPERIMENTAL | Sumatriptan succinate and naproxen sodium combination 10mg/60mg |
| Sumatriptan and Naproxen 2 | EXPERIMENTAL | Sumatriptan succinate and naproxen sodium combination 30mg/180mg |
| Sumatriptan and Naproxen 3 | EXPERIMENTAL | Sumatriptan succinate and naproxen sodium combination 85mg/500mg |
| Treximet | EXPERIMENTAL | - |
| Sumatriptan | EXPERIMENTAL | Sumatriptan |
| arm 1 | EXPERIMENTAL | Treximet (sumatriptan/naproxen sodium) |
| arm 2 | PLACEBO_COMPARATOR | placebo to match |
| Name | Type | Description |
|---|---|---|
| Sumatriptan 25 mg | DRUG | One Sumatriptan 25mg tablet and one Matching Placebo tablet should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale. |
| Sumatriptan 50 mg | DRUG | Two Sumatriptan 25mg tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale. |
| Placebo | DRUG | Two Matching Placebo tablets should be administered as soon as possible (within 30 minutes) after the development of a migraine associated with 3 or more pain on a 5-grade scale. |
| Sumatriptan and Naproxen Sodium | DRUG | Sumatriptan succinate and naproxen sodium |
| sumatriptan succinate / naproxen sodium | DRUG | sumatriptan 85mg / naproxen sodium 500mg |
| Sumatriptan Succinate | DRUG | Sumatriptan Succinate |
| sumatriptan succinate/naproxen sodium | DRUG | - |
Inclusion Criteria: * Subject is \>10 years of age and \<17 years of age at the informed consent and the Randomization Visit. * Subject has migraine with or without aura (ICHD-II criteria, 1.1 or 1.2.1). A minimum of a six month history of migraine prior to entry into the study is required. * Subje...
Top 5 of 8 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant, Ubrogepant, MEDI0618 |
| Pfizer Inc. | PFE | 11 | PHASE3 | Rimegepant, Zavegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab |
| Evommune, Inc. | EVMN | 1 | PHASE2 | EVO756 |
Sumatriptan/naproxen is used for the acute treatment of migraine, including migraine without aura, in adults and adolescents. It combines two active ingredients in a single oral dose. It is not intended for migraine prevention. GSK plc developed the combination, which has been studied in Phase 3 trials.
Sumatriptan/naproxen targets the serotonin receptors HTR1B and HTR1D as an agonist. Sumatriptan binds and activates these receptors, while naproxen is a nonsteroidal anti-inflammatory drug. Together they address migraine through serotonin receptor agonism and anti-inflammatory activity. The drug is a small molecule combination.
Sumatriptan/naproxen is developed by GSK plc, which trades under the ticker GSK. GSK conducted the Phase 3 clinical program for the combination. The drug is also known by the brand name Treximet, formerly Trexima.
Sumatriptan/naproxen has completed Phase 3 clinical development. Six Phase 3 trials are registered, all completed, with no active trials. The program enrolled 2,431 participants in randomized, double-blind studies. The trials evaluated acute migraine treatment in adults and adolescents.
Sumatriptan/naproxen has been studied in six completed Phase 3 trials, including NCT00963937 in children and adolescents in Japan, NCT00843024 in adolescents in the United States, NCT00387881 in adults with probable migraine, and NCT00356603 in Japan. All trials are completed and no active trials are ongoing.
Yes, sumatriptan/naproxen is also known as Treximet, formerly Trexima. Other names include sumatriptan succinate/naproxen sodium, sumatriptan and naproxen sodium, and sumatriptan succinate. These refer to the same fixed-dose combination product developed by GSK for acute migraine treatment.