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Label indication TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is a serotonin (5-HT 1B/1D ) receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults ( 1 ) Limitations of Use : Use only if a clear diagnosis of migraine has been established ( 1 ) Not indicated for the preventive treatment of migraine ( 1 ) Not indicated for the treatment… FDA label
Also known as Sumatriptan Succinate, PROT-CL-NP101-015.01, Zecuity®, NP101 - Sumatriptan iontophoretic transdermal patch
Sumatriptan · 2 trials · 2 indications
Adhesive Scoring Code- 0 (≥ 90% adhered (essentially no lift off of the skin)) through 4 (patch detached (patch completely off the skin))
Skin Irritation Examination Scale- 0 (no erythema) through 4 (Intense erythema with edema and blistering/erosion)
| Arm | Type | Description |
|---|---|---|
| PROT-CL-NP101-015.01 | EXPERIMENTAL | - |
| Period 1 | ACTIVE_COMPARATOR | Subject dosed with oral sumatriptan succinate during an acute migraine attack. |
| Period 2 | ACTIVE_COMPARATOR | Subject dosed with oral sumatriptan during a non-migraine period. |
| Period 3 and Period 6 | EXPERIMENTAL | Subject dosed with NP101 during an acute migraine attack. |
| Period 4 and Period 5 | EXPERIMENTAL | Subject dosed with NP101 study patch during a non-migraine period. |
| Name | Type | Description |
|---|---|---|
| PROT-CL-NP101-015.01 | DRUG | - |
| Sumatriptan succinate | DRUG | Sumatriptan succinate 50 mg taken orally |
| NP101 Study Patch | DRUG | NP101 study patch 4 hour application |
Inclusion Criteria: * Subject has a diagnosis of migraine headache, with or without aura * Subject and subject's parent or legal guardian are able to read and write English * Subject must have a negative drug screen. * Female subjects are eligible for participation provided they are of non-child be...
Sumatriptan is used to treat migraine disorders. It is a small molecule in the neurology therapeutic area. The clinical program described here covers migraine subjects, including a Phase 1 study that compared pharmacokinetics during an acute migraine attack and during a non-migraine period.
Sumatriptan targets HTR1B and HTR1D, the serotonin 5-HT1B and 5-HT1D receptors, and acts as an agonist at these receptors. This receptor activity is the basis of its use in migraine disorders.
Sumatriptan is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is listed as the developer of the sumatriptan program in migraine disorders.
Sumatriptan is in Phase 1 development for migraine disorders. The program includes one completed Phase 1 trial, and no active trials are ongoing. It is an investigational asset in clinical development rather than an approved product in this program.
Sumatriptan has been studied in the completed Phase 1 trial NCT00723983, titled a Phase I, open label, single-dose, four way crossover study comparing the pharmacokinetics of NP101 with oral Imitrex 50 mg in migraine subjects during an acute migraine attack and during a non-migraine period. It enrolled 23 participants in the United States.
Yes, sumatriptan succinate is another name for sumatriptan. The two names refer to the same active substance, so readers searching for sumatriptan succinate are looking at the same drug and the same development program in migraine disorders.