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OROS® oxybutynin
OROS oxybutynin is an anticholinergic agent that blocks muscarinic receptors in the bladder smooth muscle, reducing involuntary contractions and increasing bladder capacity.
OROS oxybutynin is an anticholinergic agent that blocks muscarinic receptors in the bladder smooth muscle, reducing involuntary contractions and increasing bladder capacity. Used for Overactive bladder with symptoms of urge incontinence, urgency, and frequency, Neurogenic detrusor overactivity in spinal cord injury patients.
At a glance
| Generic name | OROS® oxybutynin |
|---|---|
| Sponsor | Alza Corporation, DE, USA |
| Drug class | Anticholinergic agent |
| Target | Muscarinic acetylcholine receptors (M1-M5, primarily M3) |
| Modality | Small molecule |
| Therapeutic area | Urology / Gastroenterology |
| Phase | Phase 3 |
Mechanism of action
Oxybutynin works by antagonizing acetylcholine at muscarinic receptors on detrusor muscle in the bladder, thereby decreasing the frequency and amplitude of bladder contractions. The OROS (osmotic release oral system) formulation provides extended-release delivery, allowing once-daily dosing with improved tolerability compared to immediate-release formulations by reducing peak plasma concentrations.
Approved indications
- Overactive bladder with symptoms of urge incontinence, urgency, and frequency
- Neurogenic detrusor overactivity in spinal cord injury patients
Common side effects
- Dry mouth
- Constipation
- Dizziness
- Somnolence
- Headache
- Blurred vision
Key clinical trials
- A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence. (PHASE3)
- Efficacy and Safety of OROS Oybutynin and TTS Oxybutynin in Middle-Aged and Elderly Women With Urinary Incontinence (PHASE3)
- A Study to Evaluate the Safety and Efficacy of OROS® Oxybutynin Chloride for the Treatment of Urge Urinary Incontinence (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OROS® oxybutynin CI brief — competitive landscape report
- OROS® oxybutynin updates RSS · CI watch RSS
- Alza Corporation, DE, USA portfolio CI