英文药名: Gelnique 3% gel(Oxybutynin)
GELNIQUE 3％（奥昔布宁 Oxybutynin）凝胶3％，局部使用
Watson and Antares Announce the Introduction of Gelnique 3%™, for the Treatment of Overactive Bladder
GELNIQUE 3% GEL (Oxybutynin)
Gelnique 3%™ (oxybutynin) gel 3%, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and frequency. Gelnique 3%™ is a clear, odorless 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 U.S. currently exceeds $2.0 billion annually.[i] Gelnique 3%™, developed by Antares and obtained through an exclusive licensing agreement by Watson, was approved by the U.S. Food & Drug Administration on December 8, 2011.
Because the active ingredient in Gelnique 3%™ 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%™ 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%™ 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%™," said Paul K. Wotton Ph.D., 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."
About Gelnique 3%™ (oxybutynin) gel 3%
Gelnique 3%™ (oxybutynin) gel 3% 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%™ delivers a consistent dose of oxybutynin through the skin over a 24-hour period, providing significant efficacy without sacrificing tolerability.
In a Phase 3 study, 84 mg, once-daily Gelnique 3%™ 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%™ demonstrated a significant median reduction in urinary incontinence episodes (67%) versus placebo (50%) 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.
Important Safety Information
The most commonly reported adverse events associated with the use of Gelnique 3% included dry mouth (12.1%), application site erythema (3.7%), and application site rash (3.3%). Gelnique 3% 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% 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% 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.