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First and Only Topical Gel Provides Ease, Efficacy and Excellent Tolerability
CORONA, Calif., Jan. 27 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leader in generic and specialty branded pharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has approved GELNIQUE(TM) (oxybutynin chloride) Gel 10%, the first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. The U.S. OAB market currently exceeds $1.8 billion annually and continues to grow each year.
GELNIQUE will provide OAB patients with an effective and novel alternative to currently available oral treatment options. Because the active ingredient in GELNIQUE is delivered transdermally, it is not metabolized by the liver in the same way as orally administered oxybutynin. This results in a low level of side effects, such as dry mouth and constipation. GELNIQUE will be actively marketed to physicians, and Watson anticipates that the product will be made available to patients in the second quarter of this year.
"Based on the results of a clinical trial, which showed strong efficacy and excellent tolerability, and considering its unique delivery system, we expect that GELNIQUE will be used as a first-line therapy for the treatment of OAB," said Paul Bisaro, Chief Executive Officer of Watson. He added, "With this approval, which comes on the heels of the FDA approval of RAPAFLOTM (silodosin), a treatment for the signs and symptoms of benign prostatic hyperplasia (BPH), and the acceptance of the NDA for Watson's six-month formulation of TRELSTAR(R) for the palliative treatment of advanced prostate cancer, Watson is clearly establishing itself as a major force in Urology."
About GELNIQUE
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