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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 4 hour application |
| sumatriptan succinate | DRUG | tablet, 100 mg |
Inclusion Criteria: * Subject was previously enrolled in study NP101-007 and treated (patch activation) a qualifying migraine. * Subject will be judged to be in good health, based upon the results of a medical history, physical examination, vital signs, and ECG. Subjects will not have any clinicall...
NP101 is an investigational small molecule patch developed by Teva Pharmaceutical Industries Limited for migraine disorders. It is designed as a transdermal patch formulation, and clinical work has focused on acute migraine treatment and on comparing the patch with oral sumatriptan, marketed as Imitrex. NP101 remains in clinical development.
NP101 is being studied for the treatment of acute migraine. Two completed Phase 3 open-label trials, NCT00806546 and NCT00792103, evaluated its safety in adults with acute migraine over twelve months, enrolling 514 and 198 participants respectively. It is investigational and has not been established as an approved migraine therapy.
NP101 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the clinical program, including the bioequivalence and long-term safety studies conducted in the United States.
NP101 is in Phase 1 development according to its current development stage, though its clinical program also includes completed Phase 3 safety studies in acute migraine. It is investigational and is not described as FDA approved. Both listed trials are completed, and no trials are currently active.
NP101 has been studied in completed trials including NCT01381796, a Phase 1 pharmacokinetic and bioavailability study comparing two NP101 patches with oral Imitrex in 63 healthy adults, plus the Phase 3 open-label safety trials NCT00806546 and NCT00792103 in acute migraine. All are completed and no NP101 trials are currently active.
Across the NP101 clinical program, 712 participants were enrolled in total. The Phase 1 bioequivalence study NCT01381796 enrolled 63 healthy adults, while the two Phase 3 open-label migraine safety studies, NCT00806546 and NCT00792103, enrolled 514 and 198 participants respectively.