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Also known as bepotastine besilate nasal product - low dose
bepotastine besilate product- low dose · 1 trial · 1 indication
Total nasal symptom scores (TNSS) was the summed scores for nasal pruritus \[itching\], rhinorrhea \[runny nose\], nasal congestion, and sneezing. Individual nasal symptoms were 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 maximum score for increased allergic response of 12 units. The minimum possible total score was 0.
| Arm | Type | Description |
|---|---|---|
| Arm 1 - Low Dose | EXPERIMENTAL | bepotastine besilate nasal product - low dose |
| Arm 2 - Medium Dose | EXPERIMENTAL | bepotastine besilate nasal product - medium dose |
| Arm 3 - High Dose | EXPERIMENTAL | bepotastine besilate nasal product - high dose |
| Arm 4 - Placebo | PLACEBO_COMPARATOR | placebo comparator nasal product |
| Name | Type | Description |
|---|---|---|
| bepotastine besilate nasal product - low dose | DRUG | sterile nasal product |
| bepotastine besilate nasal product - medium dose | DRUG | sterile nasal product |
| bepotastine besilate nasal product - high dose | DRUG | sterile nasal product |
| placebo comparator nasal product | DRUG | sterile nasal product |
Inclusion Criteria: * Subjects 18 to 65 years of age with a positive skin prick test with ragweed allergen Exclusion Criteria: * No active respiratory tract infection
Bepotastine besilate product - low dose is an investigational small molecule developed by Bausch + Lomb Corporation (ticker BLCO) for seasonal allergic rhinitis. It is a low-dose nasal formulation studied in a Phase 1 environmental chamber trial. It is not approved and remains in clinical development.
Bepotastine besilate product - low dose is being studied for seasonal allergic rhinitis. The only clinical trial of this low-dose nasal product evaluated safety, pharmacokinetics, and efficacy after ragweed pollen exposure in an environmental chamber. It is investigational and has not been approved for any use.
Bepotastine besilate product - low dose acts as an antagonist at the HRH1 histamine receptor. By blocking HRH1, it is designed to reduce histamine-mediated allergic responses. This mechanism is consistent with its development for seasonal allergic rhinitis, though the low-dose nasal product remains investigational.
Bausch + Lomb Corporation, which trades under the ticker BLCO, is the developer of bepotastine besilate product - low dose. The company is responsible for the clinical program evaluating this low-dose nasal formulation for seasonal allergic rhinitis.
Bepotastine besilate product - low dose is in Phase 1 development. The program includes one completed Phase 1 trial, and no active trials are ongoing. It is an investigational product and has not been approved by the FDA.
Bepotastine besilate product - low dose has been studied in one completed Phase 1 trial, NCT01222299, titled "Safety, Pharmacokinetics, and Efficacy of Bepotastine Besilate Nasal Product After Ragweed Pollen Exposure in an Environmental Chamber." The randomized, double-blind, placebo-controlled trial enrolled 89 participants in the United States.
Yes, bepotastine besilate product - low dose is also known as bepotastine besilate nasal product - low dose. Both names refer to the same low-dose nasal formulation developed by Bausch + Lomb Corporation for seasonal allergic rhinitis.