Watson Pharmaceuticals announced Tuesday that its drug Gelnique has been approved by the FDA for the treatment of overactive bladder. Gelnique, oxybutynin chloride gel 10%, is the first topical treatment for the condition overactive bladder, which causes uncontrollable urination. A one gram dose of the 100mg/g gel is to be applied once a day to a body part such as the thigh, abdomen, upper arm or the shoulder.

The Food and Drug Administration approved the gel on the basis of phase III randomized studies on 789 patients with an overactive bladder. After 12 weeks the results showed the gel to be more effective at reducing the urge to urinate and helped reduce leakage episodes as compared to the placebo.

Watson said as the drug is delivered topically it has fewer side effects than tablet based drugs already on the market have. The company said overall the gel was well tolerated and there were very few incidences of adverse reactions. None of them were serious with the most common adverse event being dry mouth which affected 6.9% and skin irritation at the application site which affected 5.4 %

The company said that other studies have found that showering one hour after applying the gel, or using sunscreen 30 minutes before or after application of the gel did not significantly change the absorption of the drug.

Watson already markets the overactive bladder patch Oxytrol and it expects to launch the drug Gelnique by late spring.