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ML Risk
NP101 · 3 trials · 2 indications
For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).
Blood samples (4 mL per sample) for PK analysis will be collected at the following times for the determination of sumatriptan concentrations in plasma for each treatment: Pre-dose (within 15 minutes prior to dosing) and at 0.25, 0.50, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hrs post-dose.
| Arm | Type | Description |
|---|---|---|
| NP101 | EXPERIMENTAL | sumatriptan iontophoretic transdermal patch |
| Treatment A - NP101 | ACTIVE_COMPARATOR | - |
| Treatment C - oral sumatriptan succinate | ACTIVE_COMPARATOR | - |
| Treatment B - NP101B | EXPERIMENTAL | - |
| Treatment D - NP101D | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| NP101 | DRUG | NP101 study patch four hour application |
| sumatriptan succinate | DRUG | tablet, 100 mg |
Inclusion Criteria: * Subject is an adult male or female, age range 18 years to 65 years. * Subject has 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. * Subject experiences mild to severe headaches during a migraine...
NP101 is an investigational small molecule being developed for the treatment of acute migraine. It is a patch formulation intended to deliver medication through the skin. Clinical trials have studied its safety in migraine patients over 12 months, and a Phase 1 study compared its pharmacokinetics and bioavailability with oral Imitrex.
NP101 is being developed by Teva Pharmaceutical Industries Limited, whose stock trades under the ticker TEVA. The company has sponsored clinical trials evaluating the drug for acute migraine treatment.
NP101 is in Phase 1 clinical development. While two Phase 3 safety studies have been completed, the most recent trial is a Phase 1 study comparing the pharmacokinetics and bioavailability of NP101 patches with oral Imitrex in healthy adults. The drug remains investigational and is not approved.
NP101 has been studied in three completed trials. NCT00792103 and NCT00806546 were open-label Phase 3 studies evaluating safety over 12 months in migraine patients, enrolling 198 and 514 participants respectively. NCT01381796 was a Phase 1 study in 63 healthy adults comparing NP101 patches with oral Imitrex.
NP101 is a small molecule patch formulation for acute migraine. It is designed to deliver medication through the skin, providing an alternative to oral administration. The active ingredient is intended to target migraine pathways, though the specific molecular target has not been disclosed.