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 EnteraGam having significant interactions with commonly prescribed medications or therapies for patients.
Since EnteraGam was introduced in the U.S. in 2013, the company reports that some 3 million doses have been administered to patients, with an overall adverse events rate of less than 0.2%. No serious adverse events are attributed to its use.
RedHill also has entered into an exclusive co-promotion agreement with a subsidiary of Concordia International Corporation in January 2017, granting the company with certain U.S. promotional rights for Donnatal. Donnatal (belladonna alkaloids, phenobarbital) combines an anticholinergic/antispasmodic drug and a barbiturate sedative, and is used to treat abdominal pain, bloating and cramps in patients with irritable bowel syndrome. It is recognized by the FDA as “possibly” effective adjunctive therapy for IBS and acute enterocolitis.
“We look forward to initiating the promotion of Donnatal® and EnteraGam® in mid-2017. We are currently in advanced stages of building RedHill’s commercial operations in the U.S. and are excited to complement our product portfolio with a second commercial product geared towards gastroenterologists,” Guy Goldberg, RedHill’s chief business officer, said in a press release.
“In parallel, we continue to advance the development of our three Phase III GI products, which, if approved by the FDA, we intend to commercialize in the U.S,” Adi Frish, RedHill’s senior vice president, business development and licensing, said. The company is in advanced clinical testing of Crohn’s disease, and gastroenteritis and gastritis.
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