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Novartis/P&G incontinence drug beats J&J rival in study

Data from a head-to-head clinical study of two prescription incontinence drugs have revealed that treatment with Novartis and Procter & Gamble's Enablex did not result in impaired memory function in healthy adults age 60 and older, whereas Ortho-McNeil's Ditropan XL caused significant memory deterioration.

Enablex (darifenacin) and Ditropan XL (oxybutynin extended-release) are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. Both therapies are antimuscarinic agents, meaning they act on muscarinic receptors in the body associated with bladder control.

The data are analyses of results from a multi-center, randomized, three-week study involving 150 healthy adults aged 60 or older. Results at three weeks suggest that Enablex (15mg) had no significant effect on memory function and was comparable to placebo, as measured by delayed recall accuracy on the name-face association test. This was the primary endpoint for this study. Other standardized memory function tests used in this study evaluated delayed recall of first-last name associations and object locations.

Importantly, the individuals receiving oxybutynin ER failed to notice the change in their memory function.

In this study, the most common adverse events (dry mouth: 26.5% Enablex, 40% oxybutynin ER; constipation: 20.4% Enablex, 4% oxybutynin ER) resulted in low rates of discontinuation.