Antares Pharma Announces Completion Of Patient Enrollment In Phase 3 Pivotal Trial Of Anturol™ For The Treatment Of Overactive Bladder

Main Category: Urology / Nephrology
Also Included In: Clinical Trials / Drug Trials
Article Date: 04 Mar 2010 - 2:00 PDT

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Antares Pharma, Inc. (NYSE Amex: AIS) announced 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."

About the Anturol Phase 3 Trial

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 three 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.

"The Phase 3 program has progressed with a high degree of commitment shown by our study participants and clinical investigators. Patients and physicians continue to express satisfaction and confidence in the treatment as evidenced by their continued participation in our Open Label Extension protocol. We would like to thank our clinical investigators and their patients for the interest and support of the Anturol program," said Dr. Kaushik J. Dave, Senior Vice President of Product Development.

About Overactive Bladder

Overactive bladder (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. OAB is typically caused when smooth muscle of the bladder undergoes involuntary contractions and may result in uncontrolled leakage and have a significant, negative impact on an individual's health and quality of life. 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.

Source
Antares Pharma

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