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Oxybutynin topical and transdermal formulations: an update
1Division of Urology, St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, MA 02135, USA. staskin@att.net
Drugs of Today (Barcelona, Spain : 1998)
|June 24, 2010
Summary
Transdermal oxybutynin gel (OTG) offers an effective treatment for overactive bladder (OAB) with fewer side effects than oral oxybutynin. This new formulation provides a well-tolerated alternative for managing OAB symptoms.
Area of Science:
- Pharmacology
- Urology
- Drug Delivery Systems
Background:
- Oral oxybutynin is a standard treatment for overactive bladder (OAB) but has low adherence due to anticholinergic side effects.
- These side effects are linked to high levels of N-desethyloxybutynin (DEO), a metabolite from oral oxybutynin's first-pass metabolism.
- Transdermal delivery bypasses first-pass metabolism, potentially reducing DEO levels and improving tolerability.
Purpose of the Study:
- To evaluate the efficacy and tolerability of oxybutynin chloride topical gel (OTG) for overactive bladder (OAB).
- To compare the safety and effectiveness of OTG against a placebo in a U.S. Phase III clinical trial.
Main Methods:
- A placebo-controlled, U.S. Phase III study was conducted.
- Oxybutynin chloride topical gel (OTG) was administered once daily.
- Efficacy and incidence of anticholinergic adverse events were assessed.
Main Results:
- OTG demonstrated significant efficacy in relieving OAB symptoms compared to placebo.
- The incidence of anticholinergic adverse events was low with OTG.
- Patients reported a convenient once-daily application and good tolerability.
Conclusions:
- Oxybutynin chloride topical gel (OTG) is an effective and well-tolerated treatment for OAB.
- OTG presents a valuable alternative to oral antimuscarinic agents, especially for patients experiencing side effects.
- The transdermal formulation improves upon the tolerability profile of traditional oral oxybutynin.
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