Anturol, which utilizes Antares’ proprietary advanced transdermal delivery (ATD) gel platform, is expected to begin pivotal phase III clinical trials during the second half of 2006.
Oxybutynin, the active ingredient of Anturol, is considered the gold standard for overactive bladder (OAB) treatment, and is currently available only in oral dose and adhesive patch formulations.
In the phase II study, which involved 48 healthy subjects receiving three different doses over 20 consecutive days, Anturol was found to be well tolerated at all doses with a reduced adverse event profile in comparison to those reported in both oral and adhesive patch formulations.
At the intermediate dose, Anturol provided oxybutynin average and peak plasma levels comparable to those previously published for the transdermal patch delivery system.
“The Anturol gel formulation appears to be an attractive alternative for patients who do not tolerate the side effects of traditional OAB therapies,” commented Dr Dario Carrara, managing director of the Antares Pharma AG. “Due to the ease of application and virtually no skin irritation, we also anticipate this product will lead to better patient compliance.”