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mometasone furoate once daily · 1 trial · 1 indication
Subjects scored severity of rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing at the time of evaluation (NOW) using an ordinal scale from 0 = none to 3 = severe. Evaluations were performed daily in the morning (AM) and evening (PM). For each evaluation, individual symptom scores were summed to a TNSS, which was then averaged for a single score across the 15 day treatment period.
Subjects scored nasal congestion/stuffiness using an ordinal scale from 0 = none to 3 = severe. Baseline was the average of the scores assessed every 15 minutes for 1 hour prior to dosing on Day 1. After dosing on Day 1, congestion was scored every 15 minutes for the 1st hour and every 30 minutes for the next 3 hours. Area under the curve (AUC) was calculated using the trapezoid rule, then standardization achieved by dividing the calculation by 4 hours. Treatment comparisons were examined using the standardized AUC(0-4 hr) of the change from baseline to hour 4 on Day 1.
| Arm | Type | Description |
|---|---|---|
| Combination1 | EXPERIMENTAL | Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily |
| Combination3 | EXPERIMENTAL | MFNS with OXY 3 sprays once daily |
| Mometasone | ACTIVE_COMPARATOR | MFNS once daily |
| Oxymetazoline | ACTIVE_COMPARATOR | OXY twice daily |
| Placebo | PLACEBO_COMPARATOR | Placebo nasal spray |
| Name | Type | Description |
|---|---|---|
| OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) | DRUG | MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM). |
| mometasone furoate nasal spray (MFNS) once daily | DRUG | MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening. |
| oxymetazoline nasal spray (OXY) twice daily | DRUG | OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning. |
| Placebo | DRUG | Matching placebo to MFNS given every morning and every evening x 2 weeks. |
Inclusion Criteria: * Must be 12 years of age or older, of either sex, and of any race. * Must have at least a 2-year documented history of SAR which exacerbates during the time period over which the subject will be participating. * Must have a documented (within the past 12 months) positive skin-p...
Mometasone furoate once daily is an investigational small molecule being studied for the treatment of seasonal allergic rhinitis. It is administered as a nasal spray and is intended for use in patients aged 12 years and older. The drug is currently in Phase 2 clinical development.
Mometasone furoate once daily is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for seasonal allergic rhinitis.
Mometasone furoate once daily is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is being evaluated for the treatment of seasonal allergic rhinitis.
Mometasone furoate once daily has one completed Phase 2 clinical trial registered under NCT00552110. The study, titled 'Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)', enrolled 707 participants aged 12 years and older.
Mometasone furoate once daily is a formulation of mometasone furoate, a corticosteroid, designed for once-daily administration. It is being studied as a nasal spray for seasonal allergic rhinitis. The once-daily dosing regimen distinguishes it from other mometasone furoate products that may require different dosing schedules.