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FDA OKs First Overactive Bladder Gel
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.
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Indication
Uroxatral® (alfuzosin HCl 10 mg extended-release tablets) is an alpha1-blocker for the treatment of the signs and symptoms of BPH.
Important Safety Information
Do not take UROXATRAL if you have liver problems or if you are taking antifungal drugs like ketoconazole or itraconazole, or HIV drugs like ritonavir.
UROXATRAL can cause a sudden drop in blood pressure, especially when starting treatment. This may lead to fainting, dizziness, and lightheadedness. Do not drive, operate machinery, or do any dangerous activity until you know how UROXATRAL will affect you. This is especially important if you already have a problem with low blood pressure or take medicines to treat high blood pressure. There may be an increased risk of low blood pressure and fainting when taking UROXATRAL in combination with blood pressure medication or nitrates, or erectile dysfunction medication.
If considering cataract surgery (clouding of the eyes), tell your eye surgeon that you are currently taking UROXATRAL or have previously been treated with an alpha-blocker.
Before taking UROXATRAL, tell your doctor if you have kidney problems.
Also, tell your doctor if you or any family member(s) have or take medications for a rare heart condition known as congenital prolongation of the QT interval.
BPH and prostate cancer can cause the same symptoms. However, UROXATRAL is not a treatment for prostate cancer.
The most common side effects with UROXATRAL are dizziness, upper respiratory tract infection, headache, and tiredness.
Please see UROXATRAL full prescribing information.
