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news.Stellar Pharmaceuticals has announced that its US licensee, Watson Pharma, has concluded the first and only placebo controlled study with Uracyst.
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This study was a multi-centre, randomized, double blind, evaluation of the efficacy and safety of Uracyst versus placebo in patients with interstitial cystitis or painful bladder syndrome.
The positive results of this study provide Watson with a good solid basis, to continue to move forward on the regulatory approval pathway.
Peter Riehl, president and CEO of Stellar, said: “The company is pleased with the positive results from this pilot study and is looking forward to assisting Watson in moving forward in obtaining required regulatory (FDA) approvals.
“The results of this study help to confirm the positive results found in an earlier 50 patient Canadian study preformed by Stellar, which began in early 2007, with the final results of that study expected to be released later in 2008. Manufacturing of clinical trial supplies for the Watson’s next controlled clinical study, to be conducted in the US, is currently in progress.”