Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FFNS · 1 trial · 1 indication
The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).
| Arm | Type | Description |
|---|---|---|
| FFNS 110 mcg QD | EXPERIMENTAL | - |
| FFNS 110 mcg BID | EXPERIMENTAL | - |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| FFNS 110 mcg QD | DRUG | Active Nasal Spray (AM) and Placebo Nasal Spray (PM) |
| FFNS 110 mcg BID | DRUG | Active Nasal Spray (AM) and Active Nasal Spray (PM) |
| Placebo Nasal Spray | DRUG | Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM) |
Inclusion Criteria: 1. Informed consent 2. Outpatient 3. Age (\>= 18 years at Visit 1 for Russia, Ukraine, and Germany; \>= 12 years at Visit 2 for all other countries) 4. Diagnosis of uncomplicated acute rhinosinusitis 5. Ability and willingness to comply with study procedures and restrictions. 6....
FFNS is an investigational small molecule developed by GSK plc (ticker GSK) for acute sinusitis, also known as acute rhinosinusitis. It is a nasal spray formulation studied at a 110 mcg once-daily dose, referred to as FFNS 110 mcg QD. It has been evaluated in a Phase 2 clinical program.
FFNS is being developed for the treatment of uncomplicated acute rhinosinusitis, commonly called acute sinusitis. The Phase 2 program enrolled 741 patients aged 12 years and older with this condition. It is investigational and has not been established as a marketed treatment.
FFNS is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 2 dose-finding study of the nasal spray in uncomplicated acute rhinosinusitis. The asset is also referred to as FFNS 110 mcg QD.
FFNS is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The completed study was a randomized, double-blind, placebo-controlled dose-finding trial in uncomplicated acute rhinosinusitis. FFNS is investigational and is not an approved therapy.
FFNS has been studied in one completed Phase 2 trial, NCT01018030, titled Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis. It was randomized, double-blind, and placebo-controlled, enrolling 741 participants across sites in Bulgaria, Canada, Czechia, Estonia, Germany, Netherlands, Norway, Poland, Russia, Spain, Sweden, and Ukraine.