Approval Probability
TA Base Rate
Adjusted LOA
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Oxybutynin · 1 trial · 2 indications
Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline.
| Arm | Type | Description |
|---|---|---|
| Oxybutynin Gel 56 mg/day | EXPERIMENTAL | - |
| Oxybutynin Gel 84 mg/day | EXPERIMENTAL | - |
| Placebo Gel | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Oxybutynin | DRUG | Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo |
| Placebo | DRUG | Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo |
Inclusion Criteria: * Overactive bladder (OAB) symptoms of urge and/or mixed UI with a predominance of urge incontinence for at least 3 months * Have a history of at least 1 - 2 urge episodes and 8 or more voids per day Exclusion Criteria: * Incontinence that is predominantly stress, insensate, o...
Oxybutynin is used for urge urinary incontinence, a condition characterized by a sudden, strong need to urinate and involuntary loss of urine. It is being developed as a topically administered gel for this indication, with the goal of reducing urinary frequency and urgency in affected patients.
Oxybutynin is being developed by Halozyme Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HALO. The company is conducting clinical research to evaluate the safety and efficacy of this topically administered gel formulation for the treatment of urge urinary incontinence.
Oxybutynin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for this topically administered gel formulation.
Oxybutynin was evaluated in a Phase 3 clinical trial registered as NCT00909181, titled "Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence." This randomized, double-blind, placebo-controlled study enrolled 626 participants in the United States and has been completed.
Oxybutynin is an active pharmaceutical ingredient used in various formulations, including oral tablets and transdermal patches. The product in development by Halozyme Therapeutics is a topically administered gel specifically studied for urge urinary incontinence. This gel formulation is distinct from other oxybutynin delivery methods.