FDA OKs First Overactive Bladder Gel
Gelnique Is the First and Only Topical Gel for Overactive Bladder
Jan. 28, 2009 -- The FDA has approved Gelnique, the first and only topical gel to treat overactive bladder.
Watson Pharmaceuticals, which makes Gelnique, announced the approval in a news release.
Gelnique's active ingredient, oxybutynin, isn't new; it's an antispasmodic agent that's already available in oral tablets and in a patch. But in gel form, that active ingredient doesn't get metabolized by the liver, curbing side effects, according to Watson Pharmaceuticals.
Watson Pharmaceuticals says the FDA approved Gelnique based on a clinical trial that included 789 patients with overactive bladder. During the 12-week trial, Gelnique trumped a placebo at reducing incontinence episodes and urinary frequency and at increasing urine void volume.
Gelnique was well tolerated in the clinical trial. Side effects included dry mouth and application site reactions; there were no serious adverse events, Watson Pharmaceuticals notes.
Gelnique, which is a prescription drug, is applied once daily to the thigh, abdomen, upper arm, or shoulder. Watson Pharmaceuticals expects to make the gel available by prescription in the second quarter of this year.