Watson reports positive Phase III data for prostate and bladder drugs

In the first trial, investigators conducted a double-blind, randomized, parallel-group trial to assess whether or not silodosin – an investigational alpha blocker – would prolong the QT interval on an electrocardiogram (ECG). QT is a measure of the heart’s electrical activity. A prolongation of the QTc (corrected for heart rate) interval favors the development of cardiac arrhythmias, which can lead to sudden death. The investigators concluded that silodosin did not demonstrate any meaningful effect on heart rate or QTc interval duration.

The second trial found that oxybutynin chloride topical gel (OTG) produces serum levels similar to an already-approved oxybutynin transdermal patch (Oxytrol), but demonstrates improved skin tolerability that may lead to greater patient acceptability and use. As expected, dry mouth and application site dermatitis were the only treatment-related side effects reported in more than 2% of participants. OTG is designed to provide the same advantages as the patch over a pill formulation, in terms of convenience, ease of delivery, and a lower risk of anticholinergic side effects such as dry mouth and constipation.

Edward Heimers, Jr, executive vice president and president of Watson’s Brand Division, said: “We are extremely encouraged by the results demonstrated in these two trials, as they support the safety of silodosin and the potential efficacy of OTG as well as offer important patient benefits. A marketing application for silodosin has been filed with the FDA, and one for OTG will be filed. Both products represent potentially important additions to the expanding Watson urology franchise.”