Navigation Links
Ocera Therapeutics receives CE Mark for Zysa™ for the treatment of diarrhea-predominant Irritable Bowel Syndrome (IBS-d)

SAN DIEGO, May 18, 2012 /PRNewswire/ -- Ocera Therapeutics Inc., a privately-held biopharmaceutical company focused on the development and commercialization of proprietary agents to treat gastrointestinal and liver diseases, announced today that it has received a CE Mark for Zysa™ (spherical carbon adsorbent, formerly AST-120) for the treatment of diarrhea predominant IBS (IBS-d), a condition affecting 10-15% of the Western world.  Zysa is now ready for clinical use in the EU and countries that recognize the CE Mark. Ocera is in active discussions with potential partners for European sales and marketing.

"IBS-d is a condition affecting millions of people for which no new treatment has been approved in decades," stated Dr. Laurent Fischer, President and CEO of Ocera Therapeutics. "By securing a CE Marking for Zysa, we will, with the right partner, be able to offer a new option for the treatment of this disorder that adversely affects the lives of millions of people."   

Zysa is an oral adsorbent that removes substances that may potentiate gut secretion and contraction, thereby triggering symptoms of IBS. These include abdominal pain, diarrhea and bloating.  Zysa is also marketed as Kremezin™ in Asia to treat chronic kidney disease.

IBS can be extremely debilitating and is associated with economic burden in both direct medical costs and indirect social costs such as absenteeism and lost productivity, along with decreased quality of life.  It represents the most common diagnosis made by gastroenterologists.

In a phase 2 clinical study of patients fulfilling the Rome III criteria for IBS, 26.8% of patients treated with Zysa reported a 50% or more reduction in the number of days with abdominal pain from baseline, compared to only 10.2% of patients treated with placebo (p=0.029) at Week 4. At Week 8, response rates were 32.1 and 25.4% respectively (not statistically significant). Patients treated 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 spherical carbon adsorbent with a selective adsorption profile for a variety of substances linked to IBS-d. Zysa also adsorbs other substances including ammonia, indoles (serotonin), histamine, bile acids, advanced glycation endproducts (AGE), and certain bacterial toxins. Ocera licensed the compound from Kureha Corporation (Japan). Zysa has been used chronically by over 360,000 patients and studied in over 3,000 patients worldwide. It is marketed as Kremezin™ in Asia.

About Ocera Therapeutics, Inc.
Ocera Therapeutics, based in San Diego, California, USA, is a privately-held biopharmaceutical company focused on the development and commercialization of proprietary compounds to treat liver diseases and gastrointestinal disorders.  In addition to Zysa™ (spherical carbon adsorbent), Ocera is developing OCR-002, an ammonia detoxification agent, for the treatment of patients with hepatic encephalopathy and acute liver failure. Ocera has raised over $60 million in financing from Domain Associates, Sofinnova Ventures, Thomas, McNerney & Partners, Greenspring Global Partners and InterWest Partners. Additional information on the company can be found at

SOURCE Ocera Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Ocera Therapeutics, Inc. Completes Enrollment in FHAST1, a Pivotal Phase 3 Clinical Trial in Fistulizing Crohns Disease
2. Vicus Therapeutics to Present at the 234th American Chemical Society National Meeting in Boston, MA
3. Allos Therapeutics Initiates Study of PDX in Patients with Cutaneous T-Cell Lymphoma
4. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
5. TorreyPines Therapeutics Completes Patient Enrollment in Phase IIb Clinical Trial of Tezampanel for the Treatment of Acute Migraine Headache
6. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
7. Pharmacopeia Assists the World Health Organization in the Discovery of Novel Therapeutics for the Treatment of Malaria
8. Protalix BioTherapeutics Treats First Patient in Phase III Clinical Trial of prGCD
9. TorreyPines Therapeutics Initiates a Phase I Multiple Dose Clinical Trial of Tezampanel
10. TorreyPines Therapeutics Completes Phase I Multiple Dose Clinical Trial of NGX267, a Selective M1 Agonist for the Potential Treatment of Cognitive Impairment Associated with Schizophrenia
11. Cell Therapeutics, Inc. (CTI) Launches Phase III Study for Pixantrone in Relapsed Indolent Non-Hodgkins Lymphoma (NHL)
Post Your Comments:
(Date:11/26/2015)... 2015 ) has ... of High Viscosity Drugs" report to their ... the addition of the "Self Administration of ... --> Research and Markets ( ... "Self Administration of High Viscosity Drugs" report ...
(Date:11/26/2015)... , November 26, 2015 /PRNewswire/ ... announced the addition of the  "2016 ... the European Cell Surface Marker Testing ... Opportunities"  report to their offering.  ... the addition of the  "2016 Future ...
(Date:11/25/2015)... Calif. , Nov. 25, 2015  Amgen (NASDAQ: ... Biologics License Application (BLA) with the United ... for ABP 501, a biosimilar candidate to Humira ® ... adalimumab biosimilar application submitted to the FDA and represents ... Sean E. Harper , M.D., executive vice ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 28, 2015 , ... There is only one major question facing ... last year? , This question has not been an easy question to answer. Especially ... age and the younger workforce don’t share the same discipline around working long hours. ...
(Date:11/27/2015)... Angeles, CA (PRWEB) , ... November 27, 2015 , ... ... study carried out by the University of Toronto and the University of British Columbia ... of hospitalizations for head injuries. The article explains that part of the reason for ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... in America. As people age, more care is needed, especially with Alzheimer’s, dementia ... medical professionals are being overworked. The forgotten part of this equation: 80 percent ...
(Date:11/27/2015)... ... November 27, 2015 , ... An inventor, ... to dispense prescription medications at home, so he invented the patent-pending ELECTRONIC M.D. ... dispense prescription medications. In doing so, it could help to prevent potential overdose ...
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... Lizzie’s ... , The company is offering customers 10% off of their purchase of lice treatment ... treatment at full price. According to a company spokesperson. “Finding lice is a sure ...
Breaking Medicine News(10 mins):