Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Azelastine, Fluticasone · 2 trials · 1 indication
Effect of fluticasone propionate (FLU) on the relative bioavailability (AUC0-∞) of azelastine hydrochloride (AZE) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing FLU (i.e. AZE alone; REF).
Effect of azelastine hydrochloride (AZE) on the relative bioavailability (AUC0-∞) of fluticasone propionate (FLU) when administered as fixed AZE-FLU combination product (TEST) compared to a similar formulation without containing AZE (i.e. FLU alone in the MP29-02 vehicle; REF).
| Arm | Type | Description |
|---|---|---|
| Azelastine, Fluticasone | EXPERIMENTAL | TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray |
| Azelastine mono | ACTIVE_COMPARATOR | REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies) |
| Azelastine | ACTIVE_COMPARATOR | COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product) |
| Fluticasone mono | ACTIVE_COMPARATOR | REF = FLU mono Fluticasone Propionate nasal spray (= essentially combination product formulation without any AZE; US FLU mono formulation as used in pivotal studies) |
| Fluticasone | ACTIVE_COMPARATOR | COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product) |
| Name | Type | Description |
|---|---|---|
| Azelastine, Fluticasone | DRUG | TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray |
| Azelastine mono | DRUG | REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies) |
| Azelastine | DRUG | COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product) |
| Fluticasone mono | DRUG | REF = FLU mono Fluticasone Propionate nasal spray (= essentially combination product formulation without any AZE; US FLU mono formulation as used in pivotal studies) |
| Fluticasone | DRUG | COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product) |
Inclusion Criteria: 1. Male or female healthy subjects of any Ethnic origin, age from 18 to 45 years. 2. Body mass index (BMI) from 18.5 to 30.0 kg/m2. 3. Use of adequate double contraception by female with childbearing potential (i.e. women of child bearing potential using a highly effective metho...
Top 1 of 3 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150 |
Azelastine and fluticasone is an intranasal fixed-combination product being developed for allergic rhinitis. It combines an antihistamine with a corticosteroid in a single nasal spray. Viatris Inc. (ticker VTRS) is the developer, and the program is in Phase 1 clinical development.
Azelastine and fluticasone targets HRH1, the histamine H1 receptor, as an antagonist. Azelastine acts as an HRH1 antagonist, while fluticasone is a corticosteroid component of the fixed combination. The HRH1 antagonism is the mechanism described for the antihistamine portion of this intranasal product.
Viatris Inc., which trades under the ticker VTRS, is the developer of the azelastine and fluticasone fixed-combination nasal product. The company is responsible for the clinical development program in allergic rhinitis.
Azelastine and fluticasone is in Phase 1 clinical development. Both of its recorded trials are Phase 1 pharmacokinetic studies that have been completed. The program is investigational and has not been approved by the FDA.
Azelastine and fluticasone has two completed Phase 1 trials: NCT01194622, which studied single-dose intranasal fluticasone pharmacokinetics from the fixed combination versus two fluticasone nasal sprays, and NCT01190852, which studied single-dose intranasal azelastine pharmacokinetics from the fixed combination versus azelastine nasal sprays. Both enrolled 30 participants in Germany.