Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pseudoephedrine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| FEX 60 mg | ACTIVE_COMPARATOR | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 1 tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg /pseudoephedrine 60 mg (fixe dose combination) |
| FEX 60 mg/PSE 60 mg | EXPERIMENTAL | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination Double-blind treatment period: 1 tablet of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 60 mg / pseudoephedrine 60 mg (fixe dose combination) |
| FEX 60 mg/PSE 120 mg | EXPERIMENTAL | Study medications is administered one hour before or two hours after a meal twice a day. Placebo lead-in period: 1 placebo tablet of fexofenadine 60 mg + 2 placebo tablets of fexofenadine 60 mg/pseudoephedrine 60 mg (fixe dose combination) Double-blind treatment period: 2 tablets of fexofenadine 30 mg/pseudoephedrine 60 mg (fixe dose combination) + 1 placebo tablet of fexofenadine 30 mg |
| Name | Type | Description |
|---|---|---|
| fexofenadine HCL (M016455) | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| fexofenadine HCL matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
| pseudoephedrine matching placebo | DRUG | Pharmaceutical form:tablet Route of administration: oral |
Inclusion criteria: \- Patients with seasonal allergic rhinitis (SAR): Patients with a history of SAR symptoms during the season when cedar pollen levels are increased for at least 2-years Exclusion criteria: * At the start of the placebo lead-in period: * Patients who are negative for IgE Ant...
Pseudoephedrine is used for seasonal allergic rhinitis, commonly known as hay fever. It is being studied in combination with fexofenadine for this condition. The drug is a small molecule and is currently in Phase 3 clinical development.
Pseudoephedrine is a decongestant that works by narrowing blood vessels in the nasal passages to reduce swelling and congestion. It is often combined with antihistamines like fexofenadine to treat symptoms of seasonal allergic rhinitis.
Sanofi (ticker: SNY) is developing pseudoephedrine. The company is conducting clinical trials to evaluate its use in combination with fexofenadine for seasonal allergic rhinitis.
Pseudoephedrine is in Phase 3 clinical development. It is being studied in a completed Phase 3 trial for seasonal allergic rhinitis, but it is not yet approved and remains investigational.
Pseudoephedrine is being studied in a Phase 3 trial with the identifier NCT01306721. This trial, titled 'Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis,' was completed and enrolled 520 participants in Japan.
Pseudoephedrine is not the same as Allegra. In the clinical trial NCT01306721, the combination of fexofenadine and pseudoephedrine was compared against Allegra, which is a brand name for fexofenadine alone. Pseudoephedrine is a decongestant, while Allegra is an antihistamine.