Watson reports positive results from overactive bladder study

The data presented from three open-label, randomized studies in healthy men and women showed that showering one hour or later, or the application of sunscreen 30 minutes before or after oxybutynin chloride topical gel (OTG) application did not significantly alter the absorption and systemic blood levels of OTG. The data also found limited transference of the drug when treated people came into contact with their untreated partner.

In the showering study, participants received OTG for 35 days. Every seven days, starting at day 14, subjects either didn’t shower or showered at one, two or six hours after dosing. At the time points tested, showering did not have a meaningful impact on delivery of the drug into the bloodstream.

In the sunscreen study, participants received OTG alone, or 30 minutes before or after applying sunscreen. All three application regimens resulted in similar oxybutynin absorption and time to maximum blood plasma concentration.

In these studies, OTG demonstrated good safety and tolerability. No treatment-related adverse events were observed, and no skin reactions to the gel application site were exhibited. In addition, there were no significant changes in vital signs among any of the trial participants between pre- and post-study evaluations.

Diane Newman, co-director of the Penn Center for Continence and Pelvic Health for division of urology at University of Pennsylvania, said: “Transdermal drug delivery through a topical gel is a widely accepted and effective technology in urology. Our data confirm that this particular gel can fit nicely into a busy woman’s daily regimen, including showering and sunscreen use, without compromising efficacy.”