Antares phase 2 study shows Anturol for overactive bladder to be 'well-tolerated'

By Lisa Kerner

Erie, Pa., Feb. 22 - Antares Pharma, Inc. said results of its phase 2 study of Anturol for overactive bladder found the gel-based transdermal treatment to be well-tolerated at all doses.

The study also found a reduced adverse event profile in comparison to those reported in both oral and adhesive patch formulations, according to a company news release.

Anturol is a clear, odorless gel formulation of oxybutynin designed to be absorbed through the skin following daily application on the abdomen, shoulders or thighs. Anturol, using Antares' proprietary Advanced Transdermal Delivery gel platform, is expected to begin pivotal phase 3 clinical trials during the second half of 2006, the company said.

Overactive bladder affects an estimated 17 million Americans, with the U.S. incontinence market expected to exceed $3 billion by 2008.

In the phase 2 study, 48 healthy subjects received three different doses of Anturol over 20 consecutive days. Antares said results showed clear evidence of dose proportionality and linear pharmacokinetics among the tested doses, with no skin irritation, according to a physician's assessment.

"The Anturol gel formulation appears to be an attractive alternative for patients who do not tolerate the side effects of traditional [overactive bladder] therapies," managing director Dario Carrara said in the release.

"Due to the ease of application and virtually no skin irritation, we also anticipate this product will lead to better patient compliance. Additionally, based on the superior plasma levels delivered by Anturol in phase 2, we believe it will demonstrate a high level of efficacy in phase 3. Scale-up and manufacturing of Anturol clinical batches is currently progressing with our contract manufacturer."

The preliminary Anturol phase 3 plan has already been reviewed by the Food and Drug Administration.

The phase 3 trial will be a double-blind, randomized, parallel, placebo-controlled, multi-center study evaluating the effect of 12 weeks of treatment with Anturol administered topically to patients with urge and mixed urinary incontinence. The study population of approximately 400 patients will receive administration of Anturol once daily, according to the release.

Antares is a specialized pharmaceutical product development company with patented drug delivery systems and injectable device engineering capabilities. The company has its U.S. headquarters in Exton, Pa.

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