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Antares Pharma Announces Positive Results from Application Site,Study for Anturol

EWING, N.J.--(BUSINESS WIRE)--Apr 19, 2007 - Antares Pharma, Inc. (AMEX: AIS) announced positive results from a recently completed site application study demonstrating that ANTUROL(R), it's oxybutynin ATD(TM) transdermal gel, was absorbed on a bioequivalent basis after a single-dose was applied to three different skin site locations.

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
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