Antares Pharma announced that it has completed enrollment in the double-blind portion of their Phase 3 trial of Anturol (transdermal oxybutynin ATD gel) for the treatment of overactive bladder (OAB). This randomized, double-blind, parallel, placebo controlled, multi-center trial was designed to evaluate the efficacy and safety of Anturol when administered topically, once daily for 12 weeks in patients predominantly with urge incontinence episodes for at least 3 months. The primary end point of the trial is efficacy versus placebo, defined as the reduction in the number of urinary incontinence episodes experienced per week. Secondary end points include changes from baseline in urinary urgency, average daily urinary frequency, patient perceptions, as well as safety and tolerability including skin irritation. Top line data from this pivotal trial, which is being conducted under a Special Protocol Assessment (SPA) from the FDA, is expected in the third quarter of this year.
Anturol is supplied in a dispensing pump and contains oxybutynin, an antispasmodic/anticholinergic agent.
For more information call (609) 359-3020 or visit www.antarespharma.com.