Approval Probability
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Phenazopyridine Tables, USP · 1 trial · 1 indication
The difference between baseline NRS for pain at 0 hours and the NRS for pain score at each scheduled time will be calculated to obtain Pain Intensity Difference (PID) at each time point 92, 4, 6, 8, 16 and 24.
| Arm | Type | Description |
|---|---|---|
| Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg | PLACEBO_COMPARATOR | - |
| Phenazopyridine Hydrochloride Tables, USP 200 mg | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg | DRUG | Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side. |
| Phenazopyridine Hydrochloride Tables, USP 200 mg | DRUG | Deep brown maroon colored, film coated round biconvex tablet debossed 'AN" obve '2' on one side and plain on the other side. |
Inclusion Criteria: * Is willing and able to provide and understand written informed consent for the study. * Is a female 18 years of age or older. * Has a clinical diagnosis of uncomplicated urinary tract infection (uUTI). * Has a reported history indicating a diagnosis of cystitis or urethritis. ...
Phenazopyridine Tablets, USP is used as an analgesic for short-term treatment of moderate-to-severe pain and burning upon urination associated with uncomplicated urinary tract infections (uUTI). It is studied in female subjects aged 18 years and older. It is a small molecule developed by Amneal Pharmaceuticals, Inc. (AMRX).
Phenazopyridine Tablets, USP targets the sodium channel proteins SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker of these targets. This target class activity underlies its use for urinary pain and burning associated with uncomplicated urinary tract infections.
Phenazopyridine Tablets, USP is developed by Amneal Pharmaceuticals, Inc., which trades under the ticker AMRX. The company is the sponsor of the clinical development program for this small molecule in uncomplicated urinary tract infections.
Phenazopyridine Tablets, USP is in Phase 3 development. It is investigational and is being studied for uncomplicated urinary tract infections. The Phase 3 trial has been completed, and no trials are currently active.
Phenazopyridine Tablets, USP has been studied in one completed Phase 3 trial, NCT01650051. That trial enrolled 424 participants and evaluated safety and efficacy as an analgesic for short-term treatment in female subjects with moderate-to-severe pain and burning upon urination associated with uncomplicated urinary tract infections. It was randomized, double-blind, and placebo-controlled, and was conducted in the United States.