General Information

Gelnique (oxybutynin chloride) is an antispasmodic, antimuscarinic agent. It acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.

Gelnique is specifically indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Gelnique is supplied as a gel designed for topical administration. The recommended initial dose of the drug is one sachet (a 1 gram unit dose (1.14 mL) of 100 mg/g) applied once daily to dry, intact skin on the abdomen, upper arms/shoulders, or thighs. Application sites should be rotated.

Mechanism of Action

Gelnique (oxybutynin chloride) is an antispasmodic, antimuscarinic agent. It acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle. In conditions characterized by involuntary detrusor contractions, cystometric studies have demonstrated that oxybutynin increases maximum urinary bladder capacity and increases the volume to first detrusor contraction.

Side Effects

Adverse events associated with the use of Gelnique may include, but are not limited to, the following:

• dry mouth
• urinary tract infection
• application site reactions
• upper respiratory tract infections
• dizziness
• nasopharyngitis

Clinical Trial Results

FDA approval of Gelnique was based on the results a single randomized, double-blind, placebo-controlled, parallel group 12-week study. The study entolled 789 subjects with symptomatic overactive bladder with an average of at least four incontinence episodes in a 3-day period and at least 8 micturitions per day. The subjects were randomized to daily applications of Gelnique 1 gram or matching placebo gel. Gelnique treatment resulted in a statistically significant decrease in the number of urinary incontinence episodes per day from baseline to endpoint (the primary efficacy endpoint) compared with placebo (p<0.0001) as well as a decrease in the average daily urinary frequency (p=0.0017) and an increase in the average urine volume per void (p=0.0018).