ExeGi Pharma Release: Health Canada Approves Visbiome Probiotic For Irritable Bowel Syndrome
Published: Sep 27, 2017
High potency probiotic formula is approved as a Natural Health Product for relief of IBS symptoms, such as abdominal discomfort, gas, and bloating
ROCKVILLE, Md.--(BUSINESS WIRE)--ExeGi Pharma, LLC., announced today that Visbiome®, a high potency probiotic, has secured Heath Canada approval as a Natural Health Product for the relief of Irritable Bowel Syndrome (IBS) symptoms, including abdominal discomfort, gas, and bloating. IBS is a common gastrointestinal disorder which affects as many as 5 million Canadians.1
The human gastrointestinal tract is home to a complex ecological community, consisting of trillions of microorganisms commonly referred to as, the human “gut flora.” The exact causes of IBS are unknown, but imbalances in the natural gut flora are considered to be a contributing factor for many patients. IBS is characterized by a variety of symptoms, including diarrhea, bloating, cramps, constipation and general abnormal bowel function. Visbiome is a probiotic product which provides live, beneficial bacteria to help support a healthy natural gut flora and contains a high potency, eight strain probiotic blend called, the De Simone Formulation.
Each packet of Visbiome contains 450 billion live, probiotic bacteria which is many times stronger than traditional probiotic products. The innovative formulation in Visbiome was originally invented by Professor Claudio De Simone, MD, more than 20 years ago in Rome, Italy. Since then, over 60 human clinical trials have been conducted on the formulation.
“Chronic IBS is a common problem in Canada and can have a significant impact on an IBS sufferer’s quality of life,” said Jeffrey Roberts, MSEd, BSc and founder of the IBS Patient Support Group, IBSPatient.org. Jeffrey began experiencing IBS symptoms as young adult and realized that it was going to be a lifelong condition. “A treatment option such as modulating the gut microbiome with high potency probiotics has proven to be a valuable tool to help many people manage some of the common symptoms of IBS.”
In late 2016, Visbiome became available in Canada to help normalize the gut flora in pouchitis patients. In conjunction with mesalamine, it can also help reduce the Ulcerative Colitis Disease Activity Index (UCDAI) in patients with mild to moderate active ulcerative colitis. The approval of Visbiome for IBS includes use in both adults and children over the age of five years old.
“We are very pleased to bring this formulation to those suffering from IBS in Canada,” noted Professor De Simone. “With this new approval, physicians now have access to an important new clinical tool for managing symptoms of IBS.”
Visbiome Regular and Unflavoured sachets are available in Canada through the website, www.visbiome.ca. For more information, please visit www.visbiome.ca or call 844-GUT-HEAL (844-488-4325). ExeGi Pharma’s exclusive commercial partner is PENDOPHARM, the specialty branded division of Pharmascience Inc., a Canadian privately-owned company and the largest pharmaceutical employer in Quebec.
Visbiome® is a probiotic consisting of eight strains of live, freeze-dried lactic acid bacteria. Visbiome is approved in Canada to help maintain the appropriate balance of beneficial bacteria in the bowel of pouchitis patients and reduces the risk of relapse in pouchitis. With this recent approval, Visbiome is also approved to provide relief of Irritable Bowel Syndrome (IBS) symptoms such as abdominal discomfort, gas, and bloating. Visbiome is currently the subject of eight clinical trials in several new disease states, including HIV, autism spectrum disorders, and liver cirrhosis.
About ExeGi Pharma
ExeGi Pharma, LLC is a biotechnology company focused on the development and commercialization of live, biotherapeutic and probiotic medicines. ExeGi’s team leverages the growing advances in the field of microbiome science to deliver novel, clinically supported live biotherapeutic and probiotic treatments for a wide variety of unmet medical needs. For more information, please visit exegipharma.com.
PENDOPHARM is a division of Pharmascience Inc., a Canadian privately-owned company. Established in 1983, Pharmascience Inc. is the largest pharmaceutical company in Quebec, with a highly-skilled workforce of 1,600 people. It commercializes nearly 300 products, including branded prescription, OTC and BTC products, as well as generic products, in Canada and with its affiliates and distributors in Europe, Asia, the Middle East, Africa and Oceania.
Strategically committed to growth, PENDOPHARM is actively engaged in licensing, partnering, developing, and marketing specialty prescription medicines as well as consumer brands. For more information, please visit www.pendopharm.com.
1 Fedorak et al. Canadian Digestive Health Foundation Public Impact Series 3: Irritable bowel syndrome in Canada. Incidence, prevalence, and direct and indirect economic impact. Can J Gastroenterology 2012
ExeGi Pharma, LLC
Jenna Sheldon, 240-428-6875