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Mometasone Furoate ,

Phase 3

Seasonal Allergic Rhinitis | Small molecule | Other |Amneal Pharmaceuticals, Inc.|Last Updated: Nov 2, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment811
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02125253Study to Compare the Therapeutic Equivalence of Mometasone Furoate Nasal Spray, 50 mcg With Nasonex Nasal Spray in the Relief of the Signs and Symptoms of Seasonal Allergic RhinitisPHASE3 COMPLETED 811Jan 1, 2014Jun 1, 2014Nov 2, 201510 United States
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Study Endpoints
Primary Endpoints
Change from Baseline rTNSS
Days 1 - 14

Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14

Total Nasal Symptom Score (TNSS)
Days 1 - 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.

Secondary Endpoints
Change in Baseline iTNSS
Days 1 - 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mometasone Furoate Nasal Spray, 50 mcgEXPERIMENTALMometasone Furoate Nasal Spray, 50 mcg. 4 actuations per day for 14 days.
Nasonex Nasal Spray, 50 mcgACTIVE_COMPARATORNasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg. 4 actuations per day for 14 days.
Placebo Nasal SprayPLACEBO_COMPARATORPlacebo of Mometasone Furoate Nasal Spray. 4 actuations per day for 14 days.
Interventions
NameTypeDescription
Mometasone Furoate Nasal Spray, 50 mcgDRUGa metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate
Nasonex Nasal Spray, 50 mcgDRUGa metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate
Placebo Nasal SprayDRUGa metered-dose, manual pump spray unit containing an aqueous suspension
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

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...

Countries:United States
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