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Generic probiotic Visbiome receives approval in Canada
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ExeGi Pharma recently received a product license from the Health Canada Natural and Non-prescription Health Products Directorate for the company’s generic probiotic, Visbiome, according to a press release.
Visbiome has been marketed under its brand name, VSL#3 (VSL Pharmaceuticals, Inc.), for nearly 15 years to reduce the risk of relapse in patients with pouchitis and, in combination with mesalamine, the activity index in patients with mild to moderate active ulcerative colitis.
The formula consists of eight strains of live, freeze-dried lactic acid bacteria. Its concentration and proportion of strains is equivalent to the original brand and the generic formulation is manufactured with the same methods and standards at the same facility, according to the release. ExeGi Pharma holds an exclusive agreement to market Visbiome with the probiotic’s developer, Claudio De Simone, MD, PhD, an international leader in the development of probiotics and human gut microflora, according to the release.
Visbiome was previously investigated in double-blind controlled trials and is the focus of nearly 60 published clinical trials, according to the release. Currently, Visbiome is being used in more than 20 trials worldwide.
“For patients managing a digestive health condition, it’s important to have continuity in treatment,” Richard Fedorak, MD, FRCPC, professor of medicine in the division of gastroenterology at the University of Alberta, said in the release. “The launch of Visbiome will mean ongoing access for Canadian patients to formulations that many have used for years to manage pouchitis and ulcerative colitis.”
Visbiome will be available for purchase in Canada by the fall, according to the release.