Ditropan XL

[Oxybutynin]

Study 1 was a forced dose escalation design, whereas the other studies used a dose adjustment design in which each patient's final dose was adjusted to a balance between improvement of incontinence symptoms and tolerability of side effects. Controlled studies included patients known to be responsive to oxybutynin or other anticholinergic medications, and these patients were maintained on a final dose for up to 2 weeks.

The efficacy results for the three controlled trials are presented in the following tables and figures.
Number of Urge Urinary Incontinence Episodes Per Week

* The difference between DITROPAN XL ® and placebo was statistically significant. * Covariate adjusted mean with missing observations set to baseline values

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Number of Urge Urinary Incontinence Episodes Per Week (continued)
* Covariate adjusted mean with missing observations set to baseline values

0.0
0.5
1.0
1.5
2.0

0 5 10 15 20 25
Time (hours)

Mean
R-Oxybutynin

Plasma

Concentration
(ngml)

Parameters (units) R-Oxybutynin S-Oxybutynin
C max (ng/ mL) 1.0 (0.6) 1.8 (1.0)
T max (h) 12.7 (5.4) 11.8 (5.3)
t 1/ 2 (h) 13.2 (6.2) 12.4 (6.1)
AUC (0-48) (ng° h/ mL) 18.4 (10.3) 34.2 (16.9)
AUC inf (ng° h/ mL) 21.3 (12.2) 39.5 (21.2)

R-Oxybutynin S-Oxybutynin R-Desethyloxybutynin S-Desethyloxybutynin
Cmax (ng/ mL) 0.7 ± 0.4 1.3 ± 0. 8 7.8 ± 3. 7 4.2 ± 2. 3
Tmax (hr) 5.0 5.0 5. 0 5.0
AUC (ng. hr/ mL) 12.8 ± 7. 0 23.7 ± 14.4 125.1 ± 66.7 73.6 ± 47.7

Study 1 n DITROPAN XL ® n Placebo
Mean Baseline 34 15.9 16 20.9
Mean (SD) Change from Baseline* 34 -15.8 (8.9) 16 -7.6 (8.6)
95% Confidence Interval for Difference (-13.6, -2.8)*
(DITROPAN XL ® -Placebo)

Study 2 n DITROPAN XL ® n oxybutynin
Mean Baseline 53 27.6 52 23.0
Mean (SD) Change from Baseline* 53 -17.6 (11.9) 52 -19.4 (11.9)
95% Confidence Interval for Difference (-2.8, 6.5)
(DITROPAN XL ® -oxybutynin)

** The difference between DITROPAN XL ® and oxybutynin fulfilled the criteria for comparable efficacy. * Covariate adjusted mean with missing observations set to baseline value

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