Watson Pharmaceuticals, Inc. and Antares Pharma, Inc. has launched Gelnique 3 per cent (oxybutynin) gel 3 per cent, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency. Gelnique 3 per cent is a clear, odourless topical gel that has been shown to be an effective and safe treatment for OAB. The product is available in a metered pump dispenser, offering patients convenient dosing.

OAB is a condition that affects more than 33 million Americans, and the treatment market in the US currently exceeds $2.0 billion annually. Gelnique 3 per cent, developed by Antares and obtained through an exclusive licensing agreement by Watson, was approved by the US Food & Drug Administration on December 8, 2011.

Because the active ingredient in Gelnique 3 per cent is delivered transdermally, in a clear, odorless gel, it is not metabolized by the liver in the same way as orally administered oxybutynin products. This is thought to result in a low level of side effects such as dry mouth and constipation, common with orally administered OAB medications.

“The launch of Gelnique 3 per cent further demonstrates Watson's commitment to invest in building a leadership position in urology, particularly in the overactive bladder market,” said Fred Wilkinson, Watson's executive vice president, Global Brands. “The clinical trial demonstrated an early treatment effect versus placebo and improved efficacy over time. In addition, Gelnique 3 per cent provides OAB patients with the convenience of once-daily dosing using a simple, precise metered-dose pump.

“We are very excited about the launch of Gelnique 3 per cent,” said Paul K. Wotton PhD, president and chief executive officer of Antares Pharma. “Watson's experience and commitment to urology coupled with their well-established and knowledgeable commercial team makes them the perfect partner to market this next generation gel product for the treatment of overactive bladder.”

Gelnique 3 per cent (oxybutynin) gel 3 per cent is a topical, translucent hydroalcoholic gel containing oxybutynin, an antispasmodic, antimuscarinic agent. Applied once daily to the thigh, abdomen, upper arm or shoulder, an 84 mg (approx. 3 mL) dose of Gelnique 3 per cent delivers a consistent dose of oxybutynin through the skin over a 24-hour period, providing significant efficacy without sacrificing tolerability.

In a phase III study, 84 mg, once-daily Gelnique 3 per cent was superior to placebo at relieving OAB symptoms including a reduction in incontinence episodes and urinary frequency, and an increase in urine void volume. Gelnique 3 per cent demonstrated a significant median reduction in urinary incontinence episodes (67 per cent) versus placebo (50 per cent) at week 12 of the clinical study supporting approval. Notably, significant reductions in incontinence episodes were seen in patients after just one week of therapy. Patients in the trial experienced more than six urinary incontinence episodes a day on average at baseline, or at the beginning of the trial.

Additional pharmacokinetic studies showed that showering one hour or later, or the application of sunscreen 30 minutes before or after gel application had no effect on the overall systemic exposure of the drug.

The most commonly reported adverse events associated with the use of Gelnique 3 per cent included dry mouth (12.1 per cent), application site erythema (3.7 per cent), and application site rash (3.3 per cent). Gelnique 3 per cent is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions.

Gelnique 3 per cent should be used with caution in patients with clinically significant bladder outflow obstruction, myasthenia gravis, gastrointestinal obstructive disorders, ulcerative colitis, intestinal atony, gastroesophageal reflux and those concurrently taking drugs that can cause or exacerbate esophagitis. Angioedema requiring hospitalization and emergency medical treatment has occurred with the first or subsequent doses of oxybutynin pills. If angioedema occurs, Gelnique 3 per cent should be discontinued and appropriate therapy promptly provided. Transference of oxybutynin to another person can occur when vigorous skin-to-skin contact is made with the application site. Patients should be instructed to avoid open flame or smoking until the gel has dried.

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).

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 leading integrated global pharmaceutical company and is engaged in the development, manufacture and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health.

Antares Pharma, Inc. focuses on self-injection pharmaceutical products and topical gel-based medicines.