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Watson Launches GELNIQUE(TM) (oxybutynin chloride) Gel 10%, First and Only Topical Gel for Overactive Bladder (OAB)
Date:5/21/2009

ience," 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.

In addition to GELNIQUE, Watson recently launched RAPAFLO(TM) (silodosin), the Company's new alpha blocker for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH), which offers rapid relief and has an exceptional safety profile. The Company also has submitted a New Drug Application for its 6-month formulation of TRELSTAR(R) (triptorelin pamoate), a luteinizing hormone releasing hormone (LHRH) agonist for the palliative treatment of advanced prostate cancer. Watson anticipates that FDA will take action on this application in the third quarter 2009.

About GELNIQUE

GELNIQUE is a quick-drying, clear and colorless, fragrance-free hydroalcoholic gel containing oxybutynin chloride, an antispasmodic antimuscarinic agent. Applied once daily to the thigh, abdomen, upper arm or shoulder, one-gram (approx. 1 mL) of GELNIQUE gel 10% delivers a consistent dose of oxybutynin through the skin over a 24-hour period, providing strong efficacy with excellent tolerability.

Because the active ingredient in GELNIQUE is delivered transdermally, it is not metabolized in the same way as orally administered oxybutynin. It bypasses fist-pass metabolism, which reduces the formation of the N-desethyloxybutynin metabolite (N-DEO), which may be linked to unwanted side effects such as dry mouth and constipation. In clinical trials, GELNIQUE users reported low levels of dry mouth (6.9%) and constipation (1.3%).

In a Phase 3, 12-week trial, one-gram, once-daily 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
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SOURCE Watson Pharmaceuticals, Inc.
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