The Food and Drug Administration has approved Gelnique, the first topical gel used to treat an overactive bladder (OAB). The maker of the gel, Watson Pharmaceuticals, intends to market the product to medical professionals and expects the treatment will be available to patients in the second quarter of the year.

 

The medical company says the FDA approved the gel based on a clinical trial that included 789 patients with overactive bladder.

An overactive bladder is caused when the bladder muscle contracts involuntarily. This may result in feelings of urgently having to go to the bathroom.

The medicine proved effective at reducing incontinence episodes and urinary frequency and at increasing urine void volume. The gel is absorbed through the skin and it is not metabolized by the liver in comparison with the drug's active ingredient, oxybutynin, taken orally. Gelnique is applied once daily to the thigh, abdomen, upper arm, or shoulder and clinical trials proved it is well tolerated.

 

Side effects may include dry mouth and application site reactions, but there were no serious adverse events during the clinical trials, the company noted.

Overactive bladder affects as many as 33 million adults in the United States.

 

Last year, the FDA approved Toviaz to treat patients with overactive bladders. Toviaz (fesoterodine fumarate) is made by Schwarz Pharma and distributed by Pfizer Inc of New York. Toviaz works by relaxing the smooth muscle tissue of the bladder to reduce urinary frequency and leakage of urine, the agency said in a statement.