Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pseudoephedrine · 1 trial · 1 indication
Weighted sum of change from baseline in Nasal Congestion Severity (NCSi) (instantaneous) scores over the first eight hours of treatment on Day 1
| Arm | Type | Description |
|---|---|---|
| pseudoephedrine hydrochloride 30 mg tablets | EXPERIMENTAL | Test product |
| placebo tablets | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| pseudoephedrine hydrochloride 30 mg tablets | DRUG | - |
| Placebo tablets | DRUG | - |
Inclusion Criteria: 1. Male or female subjects, ages 6 through 11 years, are experiencing the common cold, but are otherwise healthy. 2. Subjects have an onset of cold symptoms within the past 2.5 days before screening and are experiencing self-reported nasal congestion of at least stuffy severity ...
Pseudoephedrine is used for the temporary relief of nasal congestion associated with the common cold. It is a small molecule decongestant developed by Perrigo Company plc (ticker PRGO). The Phase 3 program studied it in children with the common cold, and the drug is intended to relieve stuffy nose symptoms rather than treat the underlying viral infection.
Pseudoephedrine targets SLC6A2, also known as the norepinephrine transporter. It acts as a releasing agent, which increases norepinephrine availability and causes blood vessels in the nasal passages to constrict. That vasoconstriction reduces swelling in the nasal mucosa and temporarily relieves congestion associated with the common cold.
Perrigo Company plc, which trades under the ticker PRGO, is the developer of the pseudoephedrine product described here. Perrigo is a consumer healthcare and pharmaceutical company, and this pseudoephedrine hydrochloride 30 mg tablet formulation was studied in a Phase 3 pediatric trial for nasal congestion associated with the common cold.
Pseudoephedrine hydrochloride 30 mg tablets have been studied in a Phase 3 clinical trial for nasal congestion associated with the common cold. That trial, NCT01744106, is completed, and no trials for this product are currently active. The program enrolled 565 participants in the United States.
Pseudoephedrine hydrochloride 30 mg tablets were evaluated in NCT01744106, a multicenter Phase 3 study of pseudoephedrine for the temporary relief of nasal congestion in children with the common cold. The trial was randomized, double blind, and placebo controlled, enrolled 565 children aged 6 years and older, and is completed.