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Ocera Therapeutics receives CE Mark for Zysa™ for the treatment of diarrhea-predominant Irritable Bowel Syndrome (IBS-d)
Date:5/18/2012

ted with Zysa experienced improvement in bloating and stool consistency. These improvements were lost when Zysa was replaced with placebo and regained when Zysa was reinstituted.

"Zysa is a locally acting, novel treatment for IBS that has been proven safe and well-tolerated. It has been shown to reduce pain and bloating for the short-term symptomatic treatment of IBS-d," stated Professor Jan Tack, Head of Clinic, Department of Gastroenterology in Leuven, Belgium and the lead investigator of the Zysa clinical trial. "Given the paucity of proven treatments for IBS-d, Zysa has the potential to become an important new tool for gastroenterologists working with patients to combat this very common disorder."

Ocera Therapeutics has received Fast Track status from the U.S. Food and Drug Administration (FDA) for Zysa for IBS-d and is planning to initiate further studies based on recent guidance and interactions with the FDA. Zysa is protected by patents for the short-term symptomatic relief of IBS-d until 2027. Currently, the only approved treatment in the U.S. for IBS-d is alosetron, which carries significant safety concerns that necessitate a risk minimization program. As such, most patients with non‐constipating IBS are treated with drugs that are either not indicated for IBS and are of unproven or limited efficacy in this population, including antispasmodic agents, antidepressants and probiotics [Brandt 2009; Hammerle 2008].

The CE Marking is a legally required mark for a product that is intended for sale in the European Market and declares the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation. CE Marking certification was conducted by TUV SUD, a globally recognized testing, inspection and certification organization. 

About Zysa™ (spherical carbon adsorbent, AST-120)
Zysa is a novel proprietary spheric
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SOURCE Ocera Therapeutics, Inc.
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