PRODUCTS: ANTUROL®

Anturol® is a novel treatment in Phase III development for the management of overactive bladder. Using Antares' proprietary ATD™ transdermal gel system, Anturol® delivers efficacious doses of the anticholinergic drug, oxybutynin, systemically absorbed through the skin in a controlled manner.

Using a metered dose pump, Anturol® is an easy-to-use therapy available in two strengths (56 and 84 mg) allowing dose titration. Transdermal delivery of oxybutynin is not only a convenient and effective method of dosing but also significantly reduces the side effects commonly associated with oral medications for overactive bladder, e.g., dry mouth. We are currently conducting a double-blind, placebo-controlled Phase III study at multiple sites in the US and expect to file an NDA by September 2010.

The main active metabolite of oxybutynin is N-desethyloxybutynin (N-DEO), which has a similar anticholinergic effect to oxybutynin, but is primarily responsible for the anticholinergic side effects (mainly dry mouth). Transdermal administration maintains systemic availability of oxybutynin while reducing the formation of N-DEO by minimizing first-pass metabolism compared to that with oral administration.

A Phase II clinical study of Anturol® in 48 subjects demonstrated that at three different doses, the plasma levels of oxybutynin achieved were comparable to the efficacious plasma levels observed for oral and patch therapies. Furthermore, the relative plasma levels of N-DEO were significantly less than those reported for oral oxybutynin formulations and equivalent to those observed for the oxybutynin patch. Anturol® also showed superior skin tolerance compared to the patch.

Several large population studies have reported that overactive bladder affects approximately 16% of adults and that the incidence increases with age. Indeed, it is believed that around 100 million people worldwide experience symptoms of overactive bladder, with women being affected more than men. Urinary incontinence in the elderly is a particular problem with up to 50% of the inhabitants in US nursing homes suffering from symptoms.

The global market for urinary incontinence products is projected to be US$3 billion by 2011. Due to the advantages associated with reduced side effects compared to oral therapies, it is expected that non-patch transdermal products, especially in a superior gel dosage form, will gain significant market share.

Application Site Bioequivalence Study of ANTUROL™ Transdermal Oxybutynin Gel for Overactive Bladder (Poster)	[open file]
Dose-ranging Pharmacokinetic Study of ANTUROL™ Transdermal Oxybutynin Gel for Overactive Bladder (Poster)	[open file]
Pharmacokinetic Study of R/S OXY and DEO Enantiomers in ANTUROL™ Transdermal Oxybutynin Gel for Overactive Bladder (Poster)	[open file]

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