• In large controlled clinical trials, up to 83% reduction in urge urinary incontinence (UUI) episodes (15 mg dose; P<0.05 vs placebo)¹*
• Up to 84% reduction in UUI episodes sustained for 2 years¹
• Efficacy and adverse event profiles consistent with data from 12-week, controlled clinical studies
• 2 effective doses provide the ability to treat more patients

Results from a multicenter, open-label, 2-year extension study that enrolled 716 patients from two 12-week, double-blind feeder studies: (n=600 at 3 months, n=543 at 6 months, n=497 at 12 months, and n=466 at 24 months). Total number of older patients (=65 years): 199 at baseline; 173 at 3 months; 156 at 6 months; 140 at 12 months; 135 at 24 months.

ENABLEX is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency. Important information: ENABLEX is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk of these conditions. ENABLEX is also contraindicated in patients with known hypersensitivity to the drug or any of its ingredients.

*Placebo rates from clinical trials: Study A: 46%; Study B: 56%; Study C: 71%.

Documented CNS safety

• CNS adverse events similar to placebo in pivotal phase 3 clinical trials¹
• In a controlled clinical study, no significant difference to placebo on cognitive function measures⁴

Results from a multicenter, double-blind, double-dummy, parallel-group study involving 150 randomized healthy volunteers 60 years or older. Subjects were randomized to Enablex, another OAB treatment, or placebo. Active treatments were administered according to their respective US prescribing information. Results of the delayed recall Name-Face Association test at week 3 showed no difference between Enablex and placebo on delayed recall (mean difference, -0.06; p = NS). Procter & Gamble Pharmaceuticals Cincinnati, OH 45202

Important information: The incidence of the most frequently reported adverse events for ENABLEX 7.5 mg, 15 mg, and placebo was: dry mouth (20.2%, 35.3%, 8.2%); constipation (14.8%, 21.3%, 6.2%); dyspepsia (2.7%, 8.4%, 2.6%); abdominal pain (2.4%, 3.9%, 0.5%); nausea (2.7%, 1.5%, 1.5%); diarrhea (2.1%, 0.9%, 1.8%); urinary tract infection (4.7%, 4.5%, 2.6%); dizziness (0.9%, 2.1%, 1.3%); asthenia (1,5%, 2.7%, 1.3%); and dry eyes (1.5%, 2.1%, 0.5%).

More dry days

• Up to 61% of patients on ENABLEX achieved 3 or more dry days/week (Placebo rate: 48%)²
  
  Pooled results from 3 multicenter, double-blind, randomized, placebo-controlled, parallel-group, dose-response, pivotal studies involving 1059 patients with OAB symptoms for at least 6 months. After a 2-week placebo run-in phase, patients took active drug or control for 12 weeks.
  
  
• Up to 24% of patients taking ENABLEX experienced 7 or more consecutive dry days (Placebo rate: 16%; P<.05)²

Important information: ENABLEX should be administered with caution to patients with clinically significant bladder outflow obstruction, gastrointestinal obstructive disorders, severe constipation, ulcerative colitis, or myasthenia gravis. In patients being treated for narrow-angle glaucoma, ENABLEX should be used only with caution and if potential benefits outweigh the risks.

Up to 16% of patients taking placebo experienced 7 or more consecutive dry days. Please see full prescribing information provided separately.

Proven cardiac safety

• No QTc interval prolongation versus placebo in the largest published QTc study for OAB therapies
• Including 75 mg (which is 10 times the recommended starting dose)
• Cardiovascular adverse events similar to placebo in pivotal phase 3 clinical trials¹

Please see full prescribing information (PDF)

Can't view the PDF?
Click here to download Adobe Acrobat.

References:

1. Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.

2. Chapple C, Steers W, Norton P, et al. A pooled analysis of three phase III studies to investigate the efficacy, tolerability and safety of darifenacin, a muscarinic M3 selective receptor antagonist, in the treatment of overactive bladder. BJU Int. 2005;95:993-1001.

3. Serra DB, Affrime MB, Bedigian MP, et al. QT and QTc interval with standard and supratherapeutic doses of darifenacin, a muscarinic M3 receptor antagonist for the treatment of overactive bladder. J Clin Pharmacol. 2005;45:1038-1047.

4. Lipton RB, Kolodner K, Wesnes K. Assessment of cognitive function of the elderly population: effects of darifenacin. J Urol. 2005;173:493-498.

Explore P&GP Products:

Asacol ®  

Dantrium ®  

Dantrium ® IV  

Didronel ®  

Enablex ®  

Macrobid ®  

Macrodantin ®