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Bepotastine Besilate 2% Twice a day · 1 trial · 1 indication
Total nasal symptom score (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were each rated on a 4-point scale from 0-3 (0=Absent, 1=Mild, 2=Moderate, 3=Severe), with no half-unit assessments. TNSS was the sum score of 4 nasal symptoms with a minimum score of 0 units and a maximum score of 12 units, with higher score corresponding to increased nasal allergy symptoms. Morning and evening scores were averaged.
| Arm | Type | Description |
|---|---|---|
| 2% Twice a day | EXPERIMENTAL | Bepotastine Besilate Nasal Spray 2% Twice a day |
| 3% Twice a day | EXPERIMENTAL | Bepotastine Besilate Nasal Spray 3% Twice a day |
| 4% Twice a day | EXPERIMENTAL | Bepotastine Besilate Nasal Spray 4% Twice a day |
| Placebo | PLACEBO_COMPARATOR | Placebo nasal spray |
| Name | Type | Description |
|---|---|---|
| Bepotastine Besilate Nasal Spray 2% Twice a day | DRUG | nasal spray |
| Bepotastine Besilate Nasal Spray 3% Twice a day | DRUG | nasal spray |
| Bepotastine Besilate Nasal Spray 4% Twice a day | DRUG | nasal spray |
| Placebo Nasal Spray | DRUG | nasal spray |
Inclusion Criteria: * Male or female at least 12 years of age with a history of mountain cedar allergy Exclusion Criteria: * No active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
Bepotastine Besilate 2% Twice a day is an investigational small molecule being developed for the treatment of Seasonal Allergic Rhinitis. It is formulated 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.
Bepotastine Besilate 2% Twice a day is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical trials to evaluate the safety and efficacy of this nasal spray for Seasonal Allergic Rhinitis.
Bepotastine Besilate 2% Twice a day is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.
Bepotastine Besilate 2% Twice a day has been studied in one completed Phase 2 clinical trial, NCT01277341, titled 'Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis.' This randomized, double-blind, placebo-controlled trial enrolled 601 participants in the United States.
Bepotastine Besilate 2% Twice a day is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Seasonal Allergic Rhinitis. The completed Phase 2 trial evaluated its safety and efficacy, but the drug has not yet received regulatory approval.