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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 being developed for the treatment of Seasonal Allergic Rhinitis. It is administered as a nasal product and is currently in Phase 1 clinical development. The drug is being studied for its safety, pharmacokinetics, and efficacy in patients with this condition.
Bepotastine besilate product- low dose is being developed by Bausch + Lomb Corporation, a company traded on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical research on this nasal product for the treatment of Seasonal Allergic Rhinitis.
Bepotastine besilate product- low dose is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under investigation for Seasonal Allergic Rhinitis.
Bepotastine besilate product- low dose has one completed Phase 1 clinical trial registered as NCT01222299. This study evaluated the safety, pharmacokinetics, and efficacy of the nasal product after ragweed pollen exposure in an environmental chamber. The trial enrolled 89 participants in the United States and was randomized, double-blind, and placebo-controlled.
Bepotastine besilate product- low dose is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Seasonal Allergic Rhinitis. The completed Phase 1 trial was designed to assess safety and preliminary efficacy, but the drug has not yet received regulatory approval.