PRODUCTS: ANTUROL™

We are currently developing ANTUROL™ for the treatment of over active bladder (OAB). ANTUROL™ is the anticholinergic oxybutynin delivered by our proprietary ATD™ gel that is used to achieve therapeutic blood levels of the active compound that can be sustained over 24 hours after a single, daily application. It is believed that ANTUROL™ may offer equal or increased oxybutynin to the metabolite ratio, thus resulting in decreased reporting of adverse events when compared to patients taking comparable oral products. In addition, ANTUROL™ is more cosmetically appealing than patches and may have less irritation and allergic reactions.

OAB affects more than 20 million adults in the U.S. (and 100 million worldwide) and is one of the fastest growing segments in the urology market. It is characterized by involuntary muscle contractions resulting in urine leakage. Symptoms include urinary frequency, urgency and urge incontinence. While OAB may occur at any age, it is most common among the elderly, affecting up to 61% of those over 65, particularly post-menopausal women. A recent SCRIP Report showed the incontinence market growing at 40% per year.

Treatment for OAB currently consists of oral administration of compounds such as oxybutynin, Tolterodine, darifenacin, solifenacin, and trospium each of which have significant side effects, including dry mouth (seen in 70% of patients), nausea, dry eyes, and constipation. It is estimated that half of the adults suffering from OAB either are too embarrassed to discuss their symptoms or are not aware that pharmacological treatment is available. It is estimated by Cowen & Co. in their March 2006 publication that just 16% of incontinence patients were compliant with their treatment in 2005 and expected to improve modestly to only 18% in 2010.

In February 2006, the Company announced the results of its Phase II dose ranging study for ANTUROL™. The study was an open label, single period, randomized study using 48 healthy subjects and three different doses of ANTUROL™ over a 20 day period. Variables tested included accumulation of the dose, dose proportionality, decay of plasma levels, skin tolerability and other adverse events.

The overall conclusions of the study were positive. Dose proportionality occurred within the tested dosing range. A steady state was achieved after 3 applications (i.e., 3 days). Efficacy appeared comparable to oral products marketed. The incidences of dry mouth were minimal and similar to other transdermals while significantly improved over comparable oral medications. Additionally, skin tolerance (i.e. local skin irritation) was excellent.

A Phase III study of ANTUROL™ has been preliminarily approved by the FDA and will include patients with urge and mixed urinary incontinence. The study will be a multi-center study over a 12 week period with ANTUROL™ applied once a day compared to a placebo.

Learn more about ANTUROL™ by viewing the posters presented at the 2007 American Urogynecological Society Meeting in Hollywood (Florida) [ website ]

Dose-ranging Pharmacokinetic Study of ANTUROL™ Transdermal Oxybutynin Gel for Overactive Bladder
[ show poster ] 257 kB

Pharmacokinetic Study of R/S OXY and DEO Enantiomers in ANTUROL™ Transdermal Oxybutynin Gel for Overactive Bladder
[ show poster ] 235 kB

Application Site Bioequivalence Study of ANTUROL™ Transdermal Oxybutynin Gel for Overactive Bladder
[ show poster ] 345 kB

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