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A Once-daily Titratable Gel Formulation for Transdermal Oxybutynin Delivery for OAB
David R Staskin, MD3, Evan Goldfisher2, Kaushik Dave3
Tufts University School Of Medicine, Boston, MA; 2Hudson Valley Urology, Poughkeepsie, NY 3; Antares Pharma, Ewing, NJ
Introduction:
A prospective randomized double-blind placebo-controlled trial of a once-daily titrable dose transdermal oxybutynin gel (TTOG) formulation. To date there are no titrable transdermal agents for OAB.
Materials & Methods:
12 week study ages 19-89 years with symptoms of urgency (UUI) and/or mixed UI for >3 months. Inclusion: >1-2 urge episodes and >8 voids/day. Three treatment arms: 84mg and 56mg TTOG and placebo. Primary: change from baseline in (UI) using a 3-day diary. Secondary: change from baseline in urinary frequency and volume voided. Primary analysis: modified intent to treat. Diaries: baseline, and weeks 1,2,4,8, and 12. Statistics: transformation for group comparison (predefined). IRB approved. Gel formulation supplied (Anturol) and study funding by Antares Pharma, Inc., Ewing, NJ.
Results:
626 patients (87% female) were included: TTOG 84mg (N=214), 56mg (N=210), and placebo (N= 202). Both doses of TTOG were statistically superior to placebo for UUI reduction and volume voided; 84mg dose for urinary frequency (Table 1). AEs:mild to moderate / non-prompted rates of dry mouth n= 26 (12.1%)/84mg and n= 23 (11.0%)/56mg TTOG and n=10 (5.0%)/placebo. CNS AEs were similar between both active arms and placebo group.
Conclusions: This is the first report of a TTOG. Significant improvement noted for OAB symptoms at both doses. Side effects were mild to moderate with low levels of skin reactivity. TTOG provides an additional alternative for managing OAB symptoms.
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