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Fentanyl System/h+ Askina Derm Overlay · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay |
| 2 | ACTIVE_COMPARATOR | Fentanyl Transdermal System 25 mcg/h |
| Name | Type | Description |
|---|---|---|
| Fentanyl Transdermal System 25 mcg/h + Askina Derm Overlay | DRUG | single application |
| Fentanyl Transdermal System 25 mcg/h | DRUG | single application |
| Fentanyl Transdermal System 25 mcg/h + Bioclusive Overlay | DRUG | single application |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta human chorionic gonadotropin (beta-HCG) pregnancy tests performed within 21 days prior to the start of the study and on the ev...
Fentanyl System/h+ Askina Derm Overlay is an investigational transdermal fentanyl product studied with an Askina Derm overlay dressing. It is being developed by Viatris Inc. (ticker VTRS) and has been evaluated in Phase 1 clinical trials. The studies were conducted in healthy adult volunteers in the United States.
Fentanyl System/h+ Askina Derm Overlay targets OPRM1, the mu-opioid receptor, and acts as an agonist at this receptor. Fentanyl is a small molecule that binds and activates OPRM1 to produce its pharmacological effects. The product is designed for transdermal delivery at a 25 mcg/h rate.
Fentanyl System/h+ Askina Derm Overlay is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical studies evaluating this transdermal fentanyl product with an Askina Derm overlay dressing.
Fentanyl System/h+ Askina Derm Overlay is in Phase 1 development. Both of its recorded clinical trials are Phase 1 studies and have been completed. The product is investigational and has not been approved by the FDA.
Fentanyl System/h+ Askina Derm Overlay has been studied in two completed Phase 1 trials: NCT00647842, a bioequivalence and wear study enrolling 120 healthy volunteers, and NCT00647686, a bioequivalence and wear study with the Askina Derm overlay enrolling 80 healthy volunteers. Both were conducted in the United States.