Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
sumatriptan/naproxen · 7 trials · 2 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.
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 |
| 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 | 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 13 | PHASE3 | Atogepant |
| Pfizer Inc. | PFE | 9 | PHASE3 | Rimegepant |
| Eli Lilly and Company | LLY | 2 | PHASE3 | Galcanezumab |
| Amgen Inc. | AMGN | 2 | PHASE3 | Erenumab Dose 1 |
| Ki Health Partners. LLC | RVNC | 1 | - | Daxibotulinumtonix A |
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.