AA4010

AA4010 is a transmucosal film formulation of oxybutynin developed by Auxilium Pharmaceuticals for the treatment of overactive bladder (OAB). The product utilizes a mucoadhesive delivery technology, specifically the BioErodible MucoAdhesive (BEMA) technology licensed from BioDelivery Sciences International, to deliver oxybutynin through the oral mucosa. This route of administration is intended to provide systemic delivery while bypassing gastrointestinal and hepatic first-pass metabolism. By avoiding the first-pass effect, the formulation aims to reduce the formation of the metabolite N-desethyloxybutynin, which is primarily responsible for the anticholinergic side effects, such as dry mouth (xerostomia), commonly associated with oral oxybutynin. Development reached Phase I clinical trials around 2008, but the program was subsequently discontinued after the company failed to secure a development partner.

Other names

oxybutynin transmucosal filmoxybutynin BEMA