Over-the-counter IBgard for IBS receives approval in Canada
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IBgard, a peppermint oil natural health product for relieving symptoms of irritable bowel syndrome, has received approval from Health Canada’s Natural and Non-Prescription Health Products Directorate, the manufacturer announced.
IBgard (IM HealthScience) uses a novel delivery system to target the small intestine with peppermint oil microspheres, according to the release. The product is indicated for improving overall symptoms of IBS, including abdominal pain and discomfort, abdominal bloating and distension and urgency of bowel movement.
“Consumers suffering from irritable bowel syndrome now have another effective product that represents an advance in the management of IBS, because there is currently no cure for the condition and management options are limited,” Michael Epstein, MD, chief medical officer of IM HealthScience, said in a press release.
The approval follows positive safety and efficacy data from the randomized, placebo-controlled, multicenter Irritable Bowel Syndrome Response Evaluation and Safety Trial (IBSREST), which was recently presented at Digestive Disease Week 2015 in Washington, D.C.
Alicja Wojewnik, CEO and founder of Dicentra, who led the IM HealthScience initiative for Health Canada approval, said, “The IBgard claims approved by Health Canada speak to the power and credibility of the IM HealthScience robust scientific body of evidence.”
IBgard has been available as a non-prescription medical food in the U.S. since 2014.
Disclosure: Epstein and Wojewnik are both affiliated with IM HealthScience.