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Also known as Bepotastine Besilate Nasal Spray 2% Twice a day
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 nasal spray being developed for seasonal allergic rhinitis. It is a small molecule formulated for twice-daily intranasal dosing. Bausch + Lomb Corporation is developing it, and it has been studied in a Phase 2 clinical trial in the United States.
Bepotastine Besilate 2% twice a day is being developed for seasonal allergic rhinitis, a respiratory condition. The Phase 2 study enrolled 601 participants aged 12 years and older with seasonal allergic rhinitis. It is investigational and has not been approved for commercial use.
Bepotastine Besilate 2% twice a day targets HRH1, the histamine H1 receptor, and acts as an antagonist. By blocking HRH1, the drug is designed to interfere with histamine signaling that drives allergic rhinitis symptoms. HRH1 antagonism is the established mechanism for antihistamine activity in allergic conditions.
Bausch + Lomb Corporation, which trades under the ticker BLCO, is the developer of Bepotastine Besilate 2% twice a day. The company is responsible for the nasal spray program in seasonal allergic rhinitis. The asset has completed a Phase 2 trial in the United States.
Bepotastine Besilate 2% twice a day is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for seasonal allergic rhinitis.
Bepotastine Besilate 2% twice a day has been studied in NCT01277341, a completed Phase 2 trial titled Safety and Efficacy of Bepotastine Besilate Nasal Spray in the Treatment of Seasonal Allergic Rhinitis. The trial enrolled 601 participants in the United States, was randomized, double-blind, and placebo-controlled, and included participants aged 12 years and older.
Yes. Bepotastine Besilate 2% twice a day is also known as Bepotastine Besilate Nasal Spray 2% twice a day. The two names refer to the same investigational nasal spray product developed by Bausch + Lomb Corporation for seasonal allergic rhinitis. Searches using either name point to the same Phase 2 asset.