Redhill to Promote EnteraGam, Aid for IBS Patients with Chronic Diarrhea, in US

Redhill to Promote EnteraGam, Aid for IBS Patients with Chronic Diarrhea, in US
EnteraGam, a medical food product for the management of diarrhea-predominant irritable bowel syndrome (IBS-D), is now fully licensed in the United States to Redhill Biopharma, under an exclusive license agreement between RedHill and Entera Health. EnteraGam is a serum-derived bovine immunoglobulin/protein isolate (SBI) that binds microbial components, such as toxic substances released by bacteria, that upset the intestinal environment. Binding helps to prevent them from penetrating the lining of the intestine, which may contribute to chronic diarrhea or loose stools in people with specific intestinal disorders, such as IBS-D, inflammatory bowel disease (IBD), and human immunodeficiency virus (HIV)-associated enteropathy (disease in the intestine). As a medical food, EnteraGam is regulated by the U.S. Food and Drug Administration under the Orphan Drug Act; because it is not a drug, it is not subject to FDA approval. Evidence from various studies support the use of SBI in the dietary management of chronic diarrhea and loose stools, the company reports. For example, a randomized, double-blind and placebo-controlled study, conduced at one site in Ontario, Canada, evaluated oral EnteraGam on gastrointestinal symptom scores and quality of life (QoL) in subjects with IBS-D. Results, published in 2013, showed that those who took EnteraGam experienced fewer days per week with loose stools and other IBS-D–related symptoms, including abdominal discomfort and bloating.  According to Entera Health, there have been no reports of E
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