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 being developed for acute sinusitis, also known as acute rhinosinusitis. It is administered as a nasal spray and is intended to treat uncomplicated acute rhinosinusitis. The drug is currently in clinical development and has not been approved by regulatory authorities.
FFNS is a corticosteroid nasal spray. It works by reducing inflammation in the nasal passages, which helps relieve the symptoms of acute sinusitis. The active ingredient is fluticasone furoate, a glucocorticoid receptor agonist that decreases the production of inflammatory mediators in the nasal mucosa.
FFNS is being developed by GSK plc, a global biopharmaceutical company listed on the London Stock Exchange under the ticker GSK. GSK is conducting clinical trials to evaluate the safety and efficacy of FFNS for the treatment of acute sinusitis.
FFNS is in Phase 2 clinical development. A Phase 2 dose-finding study has been completed, which evaluated the drug in 741 patients with uncomplicated acute rhinosinusitis. The study was randomized, double-blind, and placebo-controlled, and it enrolled participants aged 12 years and older.
FFNS has one completed clinical trial registered as NCT01018030, titled "Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis." This Phase 2 study enrolled 741 participants across multiple countries, including Bulgaria, Canada, Czechia, Estonia, Germany, Netherlands, Norway, Poland, Russia, Spain, Sweden, and Ukraine.
Yes, FFNS refers to fluticasone furoate nasal spray. The drug is a corticosteroid formulation developed by GSK for the treatment of acute sinusitis. It is distinct from other fluticasone products, such as fluticasone propionate, and is being studied specifically for its efficacy in acute rhinosinusitis.