Antares Pharma looks to take Anturol into Phase III

Published: 1-Feb-2006

Antares Pharma has completed a Phase II clinical dose ranging study of Anturol, its lead proprietary oxybutynin Advanced Transdermal Delivery (ATD) gel for overactive bladder.


Antares Pharma has completed a Phase II clinical dose ranging study of Anturol, its lead proprietary oxybutynin Advanced Transdermal Delivery (ATD) gel for overactive bladder.

The company, headquartered in Exton, Pennsylvania, US, expects to commence Phase III trials in early 2006. As approved by the FDA, they will include a double-blind, randomised, parallel, placebo-controlled, multi-centre study evaluating the effect of 12 weeks of treatment administered topically in patients with urge and mixed urinary incontinence. The study population, expected to be 400 patients, will be administered two dose strengths once daily and with comparison to a placebo. Annual sales of leading overactive bladder products were in excess of $500m in 2004.

Antares has also announced an agreement with Patheon, a Toronto-based provider of drug development and manufacturing services, for the provision of manufacturing and scale-up support for the Phase III programme.

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