Antares Pharma completes enrollment in Phase 3 clinical trial of Anturol for OAB

Mar 2 2010

Antares Pharma, Inc. (NYSE Amex: AIS) announced today that it has completed enrollment in the double-blind portion of the Company’s Phase 3 clinical trial of Anturol™, its transdermal oxybutynin 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 U.S. Food and Drug Administration (FDA), is expected in the third quarter of this year.

Dr. Paul Wotton, President and Chief Executive Officer of Antares, said, “We are delighted to announce the completion of enrollment for this pivotal trial of Anturol, and we remain on track to file a New Drug Application, or NDA, with the U.S. FDA in 2010. 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.”