The study was an open-label, comparative three-way crossover, application site pharmacokinetic study. The trial enrolled 25 healthy subjects (80% women), aged 18 to 42, who received one dose of ANTUROL(R) applied topically on three skin sites: abdomen, thighs or shoulders alternatively with 10 days washout between doses. The results of the study were that each of the three sites evaluated delivered bioequivalent amounts of ANTUROL(R). Additionally, the ratio of plasma levels of R- to S- enantiomers of the active metabolite was lower following gel application (in comparison to higher a ratio of R- enantiomer levels known in oral products) indicating lower potential for adverse events from ANTUROL(R). Further, overall plasma levels of combined R- and S- enantiomers of the active metabolite were also lower in Anturol(R) in comparison to levels known in oral products.
Dario N. R. Carrara, Ph.D., SVP and Managing Director of the Pharmaceutical Group, commented, "We are pleased with the outcome of the study. The bioequivalence shown may allow patients to choose the most convenient site of application for ANTUROL(R) further enhancing the patient friendly benefits of our potential product. The ANTUROL Phase III protocol, will include a double blind, randomized, parallel, placebo controlled, multi-center study evaluating the effect of 12 weeks of treatment with ANTUROL(R) administered topically once daily to patients with urge and mixed urinary incontinence. We are diligently working on the ANTUROL(R) clinical program and we expect to announce the initiation of the Phase III trial sh ortly."
ANTUROL(R) ATD(TM) transdermal gel is intended to treat symptoms of overactive bladder (OAB), a lower urinary tract disorder resulting in a symptom syndrome including urgency with (OAB wet) or without (OAB dry) urge incontinence, usually with frequency and/or nocturia. OAB is estimated to affect more than more than 33 million people in the United States , and more than 22 million people in Europe. While OAB can affect a person at any age, it is most common among the elderly, with a prevalence of 33% to 61% in people over age 65. Despite its rising prevalence with age, OAB is treatable at every age. In recent published reports the market is described as one of the fastest-growing sectors in the pharmaceutical industry is and projected to exceed approximately $ 4 billion by 2010.
About Antares Pharma
Antares Pharma is a specialized pharma product development company focused on developing patented drug delivery systems and injectable device engineering capabilities. Antares' current technology platforms include its ATD(TM) Advanced Transdermal Delivery system, and its related TecTix(TM) system for topical and transmucosal delivery, its Easy Tec(TM) oral fast-melt technology, and subcutaneous injection technology platforms including both Vibex(TM) disposable mini-needle injection device and Valeo(TM)/Vision(R) reusable needle-free injection devices. Antares Pharma is committed to leveraging its multiple drug delivery platforms to add value to existing drugs and to create new pharmaceutical products and injectable devices. Overall, Antares' product pipeline, if approved, will address unmet medical needs by reducing side effect profiles, improving safety, increasing effectiveness, and improving patient compliance and convenience. Antares Pharma has corporate headquarters in Princeton Crossroads Corporate Center in Ewing, NJ, with subsidiaries performing research, development, manufacturing and product commercialization activities in Minneapoli s, Minnesota and Basel, Switzerland.
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Antares Pharma, Inc.
Stephanie M. Baldwin, 609-359-3020