Published on March 2, 2010 at 8:33 AM
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.”
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