Approval Probability
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Adjusted LOA
ML Risk
OXY combination: mometasone furoate and oxymetazoline · 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...
The OXY combination of mometasone furoate and oxymetazoline is being studied for the treatment of seasonal allergic rhinitis. It pairs mometasone furoate nasal spray with oxymetazoline nasal spray and is given together once a day. It is an investigational product and has not been approved for commercial use.
Organon & Co. (ticker OGN) is the developer of the OXY combination of mometasone furoate and oxymetazoline. The company is evaluating the combination of mometasone furoate nasal spray and oxymetazoline nasal spray for seasonal allergic rhinitis.
The OXY combination of mometasone furoate and oxymetazoline is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA.
The OXY combination of mometasone furoate and oxymetazoline has been studied in one completed Phase 2 trial, NCT00552110, titled a study of mometasone furoate nasal spray and oxymetazoline nasal spray given together once a day to treat seasonal allergic rhinitis. The trial enrolled 707 participants aged 12 years and older and was placebo-controlled and randomized.