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| |  DG DISPATCH - AUA: Extended Release Ditropan Causes Less Dry Mouth By Robert Carlson Special to DG News DALLAS, TX -- May 6, 1999 -- The new extended-release formulation of Alza Corp.’s Ditropan XL (oxybutynin) causes significantly less dry mouth than the original immediate-release version, according to a study from the University of Pittsburgh. The drugs are used in the treatment of overactive bladder, a condition which is characterised by sudden and involuntary loss of bladder control, frequent urination and the frequent urge to urinate. The condition is very common in women 80 years and older. In men, the aging process and potential obstruction by the prostate often aggravates the condition. Dry mouth is the primary reason why people discontinue their Ditropan therapy, according to the principal investigator. The side effect can become so serious that patients lose their sense of taste. The Pittsburgh researchers tested 28 healthy volunteers who took one of the formulations for four consecutive days and then the other formulation for another four-day period. The researchers evaluated the drugs’ side effects through blood tests of drug and metabolite levels, questionnaires completed by the subjects and by a spit test. In the spit test, subjects periodically were given a piece of plastic film impregnated with a bubble-gum flavour to chew on, and their saliva output was measured. The total saliva output was measured at the end of each study period. The objective measurements showed that subjects experienced considerably less dry mouth with the extended-release drug, with a median four-day saliva output of 41.9 grams versus 30.5 with the older version. The subjective ratings also showed that the immediate-release drug caused much more dry mouth. The extended-release formulation also has the advantage of once-daily dosing compared with three-times daily for the older formulation, said principal investigator Michael Chancellor, MD, associate professor, division of surgery/urology, University of Pittsburgh School of Medicine, and director of the Neuro-Urology and Urinary Incontinence Programs. Dr. Chancellor said the improvement in dry mouth was probably due to the slow absorption of extended-release oxybutynin, which eliminates the quick peak of the immediate-release formula. The extended release formulation is also absorbed in the colon, where it causes fewer side effects compared to the immediate-release drug which is mainly absorbed in the small intestine.
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