Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OPTINOSE FLUTICASONE · 1 trial · 1 indication
Part 2
| Arm | Type | Description |
|---|---|---|
| Flovent® HFA 440µg | ACTIVE_COMPARATOR | Flovent® HFA (fluticasone propionate) Inhalation Aerosol 440 µg |
| OPTINOSE™ FLUTICASONE 400µg intranasal | EXPERIMENTAL | OPTINOSE™ FLUTICASONE, single dose of 400 µg intranasally |
| Name | Type | Description |
|---|---|---|
| Flovent HFA | DRUG | - |
| OPTINOSE™ FLUTICASONE | DRUG | - |
Inclusion Criteria: 1. Male or female subjects' ages 18 to 55 years, inclusive, at screening. 2. Have a body mass index of 18 to 32 kg/m2, inclusive, and a body weight of not less than 52 kg for males and 45 kg for females. 3. Otherwise healthy mild to moderate asthmatic (Part 2) with no clinically...
OptiNose fluticasone is an investigational intranasal formulation of fluticasone being developed by OptiNose, Inc. (ticker: OPTN) for mild to moderate asthma. It is a small molecule delivered intranasally and has been studied in a Phase 1 clinical trial. It is not approved and remains in clinical development.
OptiNose fluticasone is being developed for the treatment of mild to moderate asthma. The only clinical trial of this formulation enrolled adults with mild to moderate asthma. It is investigational and has not been approved for any indication.
OptiNose fluticasone is being developed by OptiNose, Inc., which trades under the ticker OPTN. The company sponsored the Phase 1 bioavailability study of the intranasal formulation in patients with mild to moderate asthma.
OptiNose fluticasone is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval.
OptiNose fluticasone has been evaluated in one completed Phase 1 trial, NCT02266927. The study compared the bioavailability of intranasal administration of 200 and 400 µg or 400 µg alone of OptiNose fluticasone with 440 µg of Flovent HFA in 28 adults with mild to moderate asthma in Ireland.
Yes, OptiNose fluticasone and OptiNose™ fluticasone refer to the same investigational drug. The trademark symbol is part of the stylized name used by the developer, OptiNose, Inc. (OPTN).