Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Mometasone Furoate · 1 trial · 1 indication
Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14
The sum of patient-rated severity scores for four allergy symptoms : runny nose, nasal congestion, itchy nose, and sneezing based on a 4-point scale.
| Arm | Type | Description |
|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | EXPERIMENTAL | Mometasone Furoate Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
| Nasonex Nasal Spray, 50 mcg | ACTIVE_COMPARATOR | Nasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | Placebo of Mometasone Furoate Nasal Spray. 4 actuations per day for 14 days. |
| Name | Type | Description |
|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | DRUG | a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate |
| Nasonex Nasal Spray, 50 mcg | DRUG | a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate |
| Placebo Nasal Spray | DRUG | a metered-dose, manual pump spray unit containing an aqueous suspension |
Inclusion Criteria: * If female and of child-bearing potential, have a negative urine pregnancy test and is prepared to abstain from sexual intercourse or use a reliable method of contraception during the study * Documented positive allergic skin test, performed within the previous 12 months, to on...
Mometasone Furoate is used for the relief of signs and symptoms of seasonal allergic rhinitis. It is a small molecule being developed by Amneal Pharmaceuticals, Inc. (AMRX) and is currently in Phase 3 clinical development as an investigational therapy.
Mometasone Furoate is a corticosteroid that works by reducing inflammation in the nasal passages. It is administered as a nasal spray, delivering 50 mcg per dose to help alleviate the symptoms associated with seasonal allergic rhinitis.
Mometasone Furoate is being developed by Amneal Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol AMRX. The company is conducting clinical trials to evaluate the drug's effectiveness in treating seasonal allergic rhinitis.
Mometasone Furoate is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, with results expected to support a potential regulatory submission.
Mometasone Furoate has been studied in a Phase 3 clinical trial with the identifier NCT02125253. This randomized, placebo-controlled study enrolled 811 participants in the United States to compare the therapeutic equivalence of Mometasone Furoate Nasal Spray, 50 mcg with Nasonex in treating seasonal allergic rhinitis.
Mometasone Furoate is being studied as a potential generic equivalent to Nasonex. The clinical trial NCT02125253 was designed to compare the therapeutic equivalence of Mometasone Furoate Nasal Spray, 50 mcg with Nasonex Nasal Spray in relieving symptoms of seasonal allergic rhinitis.