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FDA Approves Gelnique

Watson's Gelnique (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder

CORONA, Calif., January 27, 2009 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals Inc. , a leader in generic and specialty branded pharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has approved Gelnique (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 Rapaflo (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 for the palliative treatment of advanced prostate cancer, Watson is clearly establishing itself as a major force in Urology."

Gelnique is a quick-drying, clear and colorless, fragrance-free hydroalcoholic gel containing oxybutynin chloride, an antispasmodic agent. Applied once daily to the thigh, abdomen, upper arm or shoulder, a one-gram (approx. 1 mL) dose of 100mg/g Gelnique delivers a consistent dose of oxybutynin through the skin over a 24-hour period, providing strong efficacy without sacrificing tolerability.

The approval of Gelnique is based on a Phase 3 randomized, double-blind, placebo-controlled, parallel group trial that evaluated a total of 789 patients with signs and symptoms of OAB. Over the 12-week trial, a one-gram, once-daily dose of Gelnique was superior to placebo at relieving OAB symptoms, including a reduction in incontinence episodes and urinary frequency, and an increase in urine void volume. The treatment was well tolerated in the study with a low incidence of adverse events and no treatment-related serious adverse events. The most frequently reported treatment-related adverse events (>2% and greater than placebo) were dry mouth (6.9%) and application-site reactions (5.4%).

Additional pharmacology studies showed that showering one hour or later, or the application of sunscreen 30 minutes before or after Gelnique application did not significantly alter the absorption of the drug.

OAB is characterized by a sudden, uncomfortable need to urinate with or without urge incontinence (urine leakage), and usually includes more frequent urination and nocturia (waking up at least once during the night to urinate). It affects as many as 33 million adults in the U.S. - more than diabetes or asthma.

More than an "inconvenience," OAB is disabling and associated with a marked decrease in health-related quality of life as well as higher rates of depression. The disease affects both men and women however, women experience more severe symptoms earlier in life.

Watson Pharmaceuticals, Inc. is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of branded pharmaceuticals focused on Urology, Gynecology and Nephrology (Medical).

In the U.S., the Watson portfolio includes Rapaflo, Oxytrol; Ferrlecit, INFeD, Trelstar LA; and Trelstar Depot. In addition, Watson markets the following brands under co-promotion agreements: AndroGel, with Solvay Pharmaceuticals, Inc.; Proquin XR, with Depomed, Inc.; Tri-Luma Cream, with Galderma Laboratories; and Femring, with Warner Chilcott Limited. The Watson pipeline portfolio includes a number of products, including a six-month formulation of Trelstar, for the treatment of advanced prostate cancer which is currently under review by the FDA; URACYST, under development for cystitis; and a novel new oral contraceptive.

Posted: January 2009

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