Overactive bladder is a medical condition affecting both men and women, which is characterized by urinary urgency and increased frequency of urination. According to an article published in The Journal of Urology in August 2002, overactive bladder affects an estimated 13 million people in the US. Based on data from the RxList, the internet drug index, we estimate sales of pharmaceutical products for overactive bladder exceeded $1 billion in 2004.

A leading oral treatment option for overactive bladder is oxybutynin in both immediate-release and extended-release forms. The published side effects of these drugs are dry mouth, gastrointestinal disorders, difficulty in concentration, and visual disturbances. These side effects may impact patient compliance and persistency. A recently introduced transdermal patch, which is applied to the skin once every three days, appears to have equivalent efficacy to oral medications, such as oxybutynin IR, but with better systemic tolerability; the downside is skin reactions at patch application sites. It is hypothesized that delivering oxybutinin via a transmucosal film will help avoid the systemic side effects without concerns for local irritation. Auxilium will pursue partnering and licensing opportunities for oxybutynin.