Anturol gel Phase 3 trial conducted under a special protocol assessment (SPA) with FDA, was a double blind, randomised, parallel placebo-controlled multi-center study which evaluated the efficacy and safety of Anturol in patients with overactive bladder.
Anturol gel Phase 3 study primary objective was to show that daily treatment of an 84mg or 56mg dose of Oxybutynin applied in the ATDTM gel technology for 12 weeks was superior to placebo for the relief of OAB symptoms.
Whereas, the secondary endpoints of the study are changes from baseline in average daily urinary frequency, void volume, patient perceptions, as well as safety and tolerability including skin irritation.
Antares Pharma said that the 84mg dose provided positive results for the secondary end points of urinary frequency and volume while the 56mg dose did not reach statistical significance.
Additionally, Anturol which uses the proprietary ATD Gel technology was well tolerated in the study.
Paul Wotton president and CEO of Antares, said: “We are delighted with the positive outcome of this Phase 3 trial, as both doses demonstrated a reduction in the primary endpoint of urinary incontinence events. We are on track to file a new drug application (NDA) with the FDA in 2010.”
Roger Dmochowski, professor of department of urologic surgery at Vanderbilt University, said: “Anturol is dispensed in a patient friendly metered dose pump which provides convenient dosing options.
“Both doses tested in the Phase 3 trial demonstrated a low incidence of side effects and the data also show that Anturol effectively reduces urinary incontinence episodes within seven days of beginning treatment compared to placebo.”