Watson Pharmaceuticals, a leader in generic and specialty branded pharmaceuticals, launched Gelnique (oxybutynin chloride) gel 10%, first and only topical gel for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency.
While Gelnique is approved for use in men as well as women, Watson has opted to target the active, female OAB patient in its marketing efforts. The Gelnique marketing campaign will highlight the power of control Gelnique offers to OAB patients rather than focusing, as traditional products have, on the predictable embarrassment and stigma associated with OAB.
"As the first and only topical gel for OAB, we believe that Gelnique provides physicians and their patients with an effective, easy first-line drug treatment option," said Paul Bisaro, chief executive officer of Watson. "Because Gelnique is a first, we are launching our product with a unique promotional campaign, one that speaks to health care professionals and patients with language and images that are empowering. We believe we can successfully position this new treatment option in a way that differentiates our product, and our message in a category that has been dominated by big pharma's tired and traditional promotion for years."
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 34 million adults in the US - more than diabetes or asthma. The US OAB market currently exceeds $1.8 billion annually and continues to grow each year. 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.
In addition to Gelnique, Watson recently launched Rapaflo (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 six-month formulation of Trelstar (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.
Gelnique is a quick-drying, clear and colourless, 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 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 and application-site reactions (5.4%).
Additional pharmacology studies showed that showering one hour or later, or applying sunscreen lotion 30 minutes before or after Gelnique application, did not significantly alter the absorption of the drug.