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>