Antares Pharma reports positive results from Anturol Gel Phase 3 study in overactive bladder patients

Antares PharmaJul 28 2010

Antares Pharma, Inc. (NYSE Amex:AIS) announced today positive results from its Phase 3 study of Anturol^TM Gel in patients with overactive bladder (OAB). The study met its primary endpoint of a statistically significant reduction in urinary incontinence episodes for both doses studied.

The Phase 3 trial conducted under a Special Protocol Assessment (SPA) with FDA was a double blind, randomized, parallel placebo-controlled multi-center study and evaluated the efficacy and safety of Anturol in 600 patients with overactive bladder. The primary objective of the study was to demonstrate that daily treatment of an 84mg or 56mg dose of oxybutynin applied in the ATD^TM Gel technology for 12 weeks was superior to placebo for the relief of OAB symptoms.

Paul. K. Wotton Ph.D., President and Chief Executive Officer of Antares said "This success represents another key accomplishment in 2010 and continues to demonstrate our strong development capabilities. Anturol is one of many value drivers in our advancing pipeline of development products. We are delighted with the positive outcome of this Phase 3 trial, as both doses demonstrated a statistically significant reduction in the primary endpoint of urinary incontinence events as well as a low incidence of reported side effects. We are on track to file a new drug application (NDA) with the FDA in 2010."

Roger R. Dmochowski M.D., FACS, Professor, Vanderbilt University, Department of Urologic Surgery stated "Anturol potentially offers many advantages for the treatment of OAB. 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."

Secondary end points included changes from baseline in average daily urinary frequency, void volume, patient perceptions, as well as safety and tolerability including skin irritation. Although not the basis for approval, the 84 mg dose provided highly statistical significant results for the secondary end points of urinary frequency and volume while the 56 mg dose did not reach statistical significance. Additionally, Anturol which uses the proprietary ATD Gel technology was well tolerated in the study. No serious adverse events related to the treatment were reported. Anticholinergic side effects such as dry mouth and constipation were low and no CNS side effects were seen compared to placebo. Treatment-related adverse events that resulted in study discontinuation during the double-blind period were low and similar for both the treatment and placebo groups.