Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sumatriptan · 4 trials · 2 indications
The primary objective was to compare the pharmacokinetics (PK) of NP101 (sumatriptan iontophoretic transdermal patch) with the currently approved oral, subcutaneous injection and nasal spray formulations of Imitrex® in healthy volunteers and to assess the bioavailability relative to the 6 mg subcutaneous injection.
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| 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. |
| A | EXPERIMENTAL | NP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver \~ 10 mg of sumatriptan utilizing up to 600 mA minutes. |
| B | ACTIVE_COMPARATOR | Sumatriptan succinate (Imitrex®) tablet: 100 mg orally. |
| C | ACTIVE_COMPARATOR | Sumatriptan succinate (Imitrex®) injection: 6 mg subcutaneously (SQ). |
| D | ACTIVE_COMPARATOR | Sumatriptan (Imitrex®) nasal spray: 20 mg (one spray) intranasal (IN) into one nostril. |
| E | EXPERIMENTAL | NP101 patch applied to the upper arm and left in place for 4 hours. The NP101 patch is designed to deliver \~ 10 mg of sumatriptan utilizing up to 600 mA minutes. |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Sumatriptan succinate | DRUG | Sumatriptan succinate 50 mg taken orally |
| NP101 Study Patch | DRUG | NP101 study patch 4 hour application |
| Imitrex® | DRUG | 100 mg Tablet |
Inclusion Criteria: * Adult male and female subjects, between the ages of 18 to 65 years. * Subjects with a diagnosis of migraine headache, with or without aura, as defined in the ICHD-II, and the diagnosis was made before the age of 50. * The majority of a subject's headaches during a migraine att...
Sumatriptan is a small molecule drug being studied for use in healthy volunteers and in people with migraine disorders. It is currently in Phase 1 clinical development, meaning it is investigational and has not been approved for any use. The drug is being developed by Teva Pharmaceutical Industries Limited.
Sumatriptan is a small molecule drug. The specific molecular target or target class for Sumatriptan has not been disclosed in the available information, so its mechanism of action is not described here.
Sumatriptan is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker symbol TEVA. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy volunteers and in patients with migraine disorders.
Sumatriptan is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three clinical trials for Sumatriptan have been completed, with no active trials currently ongoing.
Sumatriptan has been studied in three completed Phase 1 trials. These include NCT00546650, comparing a transdermal patch with Imitrex formulations in healthy subjects; NCT00723983, a pharmacokinetic study in migraine patients; and NCT00846885 and NCT00847405, bioequivalence studies of 100 mg tablets under fasting and non-fasting conditions.
Sumatriptan is not the same as Imitrex, but it is being compared with Imitrex in clinical trials. Imitrex is a brand name for sumatriptan, and the trials are evaluating different formulations of sumatriptan, including a transdermal patch and oral tablets, against Imitrex.