Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Fluticasone Propionate · 5 trials · 4 indications
: Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
Subjects reported nasal symptoms using the electronic diary twice daily immediately before dosing. 0: None 1. Mild, symptoms clearly present, but minimal awareness, and easily tolerated 2. Moderate, definite awareness of symptoms that is bothersome but tolerable 3. Severe, symptoms that are hard to tolerate, cause interference with activities or daily living The change from baseline in instantaneous morning diary symptom scores averaged over 7 days prior to the Week 4 Visit of the double-blind treatment phase
Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. A summary of the changes from baseline to Week 16 in total polyp grade. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate Reduction in total polyp grade (sum of scores from both nasal cavities) at Week 16 of double-blind treatment phase; Included patients with nasal polyps at baseline
Patients with at least one Adverse Events
| Arm | Type | Description |
|---|---|---|
| OPN-375 186 mcg BID | EXPERIMENTAL | - |
| OPN-375 100 μg BID | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: OPN-375 100 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Double-Blind Treatment Phase: Matching Placebo BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks |
| OPN-375 200 μg BID | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: OPN-375 200 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks |
| OPN-375 400 μg BID | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: OPN-375 400 μg BID x 16 weeks Open-Label Extension Phase: OPN-375 400 μg BID x 8 weeks |
| OPN-375 100 mcg | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: OPN-375 100 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks |
| OPN-375 200 mcg | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: OPN-375 200 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks |
| OPN-375 400 mcg | ACTIVE_COMPARATOR | Double-Blind Treatment Phase: OPN-375 400 mcg BID x 16 weeks; Open-Label Extension Phase: OPN-375 400 mcg BID x 8 weeks |
| Fluticasone | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Fluticasone Propionate | DRUG | OPN-375 186 μg BID, Delivered via exhalation delivery system |
Inclusion Criteria: 1. Men or women aged 18 years and older at Visit 1 (Baseline/Day1) 2. Women of child bearing potential must be abstinent, or if sexually active, 1. be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contracep...
Fluticasone Propionate is an investigational small molecule being developed for chronic sinusitis with or without nasal polyps, bilateral nasal polyposis, and nasal polyps. It is delivered intranasally using a novel bi-directional device developed by OptiNose, Inc. The drug is currently in Phase 3 clinical development for these ENT conditions.
Fluticasone Propionate is a corticosteroid that works by reducing inflammation in the nasal passages. It is administered intranasally using a bi-directional device that delivers the drug to the site of polyps and sinus inflammation. The drug is being studied for its efficacy and safety in treating nasal polyposis and chronic sinusitis.
Fluticasone Propionate is being developed by OptiNose, Inc., a company traded on the NASDAQ under the ticker OPTN. The drug is delivered using OptiNose's proprietary bi-directional delivery device, which is designed to target the nasal passages and sinuses more effectively than standard nasal sprays.
Fluticasone Propionate is in Phase 3 clinical development. It is not yet approved by the FDA and remains investigational. The drug has completed multiple Phase 3 trials evaluating its efficacy and safety for treating bilateral nasal polyposis, nasal polyps, and chronic sinusitis with or without nasal polyps.
Fluticasone Propionate has completed several Phase 3 trials, including NCT01622569, which evaluated doses of 100, 200, and 400 μg twice daily in 323 patients with bilateral nasal polyposis. NCT01623310 was a 12-month open-label safety study in 223 patients with nasal polyps. NCT01623323 assessed safety in 705 patients with chronic sinusitis with or without nasal polyps.
Fluticasone Propionate is a well-known corticosteroid, but this specific formulation is being developed by OptiNose using a novel bi-directional delivery device. It is distinct from other fluticasone nasal sprays because of the device technology, which aims to deliver the drug more effectively to the sinuses and polyp sites.