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In the two pivotal studies, no patient discontinued Oxytrol treatment due to dry mouth. Study 2 was a Phase 3 study, comparing the safety and efficacy of Oxytrol 3. Therefore, Oxytrol should not be given to pregnant women unless, in the judgment of the physician, the probable clinical benefits outweigh the possible hazards. Table 1 provides a summary of pharmacokinetic parameters of oxybutynin in healthy volunteers after single and multiple applications of Oxytrol. A total of 411 patients entered the open-label extension and of those, 65 patients and 52 patients received Oxytrol for at least 24 weeks and at least 36 weeks, respectively. The resulting plasma concentration AUC ratio of N-desethyl metabolite to parent compound following multiple Oxytrol applications was 1.

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