Antares Pharma, Inc. recently announced it has completed enrollment in the double-blind portion of the company’s Phase III clinical trial of Anturol, its transdermal oxybutin ATD gel for the treatment of overactive bladder (OAB). Top line data from this pivotal trial, which is being conducted under a Special Protocol Assessment (SPA) from the US FDA, is expected in the third quarter of this year.

“We are delighted to announce the completion of enrollment for this pivotal trial of Anturol, and we remain on track to file an NDA with the US FDA in 2010,” said Dr. Paul Wotton, President and Chief Executive Officer of Antares. “We continue to believe that Anturol offers many unique advantages over currently marketed products for the treatment of OAB. As Anturol is dispensed in a pump and applied directly to the skin once daily, potential advantages include a more reproducible and convenient dosing formulation, the ability to titrate the dosage, and potential for fewer side effects or adverse events.”

The 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 study enrolled 600 patients (approximately 200 per arm) using two doses (56 mg QD or 84 mg QD) versus placebo. 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.

OAB, also called urge incontinence, is a condition marked by sudden need to urinate that can happen at any time whether or not the bladder is full. It is estimated that more than 30 million Americans have OAB, and while it can happen at any age, it is more common among older individuals.

Antares Pharma’s subcutaneous injection technology platforms include Vibex disposable pressure-assisted auto injectors, Valeo/Vision reusable needle-free injectors, and disposable multi-use pen injectors. In the injector area, Antares has a multi-product deal with Teva Pharmaceuticals Industries, Ltd that includes Tev-Tropin human growth hormone and a partnership with Ferring Pharmaceuticals. In the gel-based area, the company's lead product candidate, Anturol, an oxybutynin ATD gel for the treatment of OAB, is currently under evaluation in a pivotal Phase III trial. Antares also has a partnership with BioSante that includes LibiGel (transdermal testosterone gel) in Phase III clinical development for the treatment of female sexual dysfunction (FSD), and Elestrin (estradiol gel) for the treatment of moderate-to-severe vasomotor symptoms associated with menopause, and currently marketed in the US.