nottoc4
07-21-2009, 11:57 AM
I read about this today in RedBook while hubbie was getting his teeth cleaned at the dentist.Sounds very interesting to me.
Watson's GELNIQUE(TM) (oxybutynin Chloride) Gel 10% Approved By FDA For The Treatment Of Overactive Bladder
Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals; Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry
Article Date: 28 Jan 2009 - 1:00 PST
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Watson Pharmaceuticals, Inc. (NYSE: WPI), a leader in generic and specialty branded pharmaceuticals, announced 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
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.
For full prescribing information, please visit http://www.gelnique.com.
About OAB
Watson's GELNIQUE(TM) (oxybutynin Chloride) Gel 10% Approved By FDA For The Treatment Of Overactive Bladder
Main Category: Urology / Nephrology
Also Included In: Regulatory Affairs / Drug Approvals; Clinical Trials / Drug Trials; Pharma Industry / Biotech Industry
Article Date: 28 Jan 2009 - 1:00 PST
email to a friend printer friendly view / write opinions rate article
Ads by Google
--------------------------------------------------------------------------------
Bladder Control Advice
Discover information and advice about bladder control, from TENA.
TENAdryfacts.com
Current Article Ratings:
Patient / Public:
Health Professional:
Article Opinions: 0 posts
Find other articles on: "oxybutynin chloride gel"
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leader in generic and specialty branded pharmaceuticals, announced 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
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.
For full prescribing information, please visit http://www.gelnique.com.
About OAB