Health Canada approves efficacy supplement for over-the-counter IBS treatment IBgard

Health Canada’s Natural and Non-Prescription Health Products Directorate has approved an efficacy supplement that increases the speed of action of IBgard, an over-the-counter treatment for irritable bowel syndrome, the manufacturer announced.

“Consumers suffering from [IBS] now have not only an effective option, but also the only option that has been shown to work within 24 hours,” Michael Epstein, MD, chief medical officer of IM HealthScience, said in a press release.

IBgard, now the only Natural Health Product licensed in Canada for 24-hour relief of IBS symptoms, uses a novel delivery system to deliver microspheres of peppermint oil to the small intestine, according to the release. The product’s previous market authorization included use for relieving overall IBS symptoms, abdominal pain and discomfort, abdominal bloating and distension, and bowel movement urgency. Its updated license now permits the label to include claims that the product “helps improve/relieve symptoms of IBS within 24 hours,” and “helps improve/relieve the intensity of symptoms of IBS within 24 hours.”

This amendment follows positive safety and efficacy results from the IBSREST randomized controlled trial. IBgard became available in 2014 in the U.S. for dietary management of IBS under medical supervision.

“As the first licensed [Natural Health Product] for the relief of IBS within 24 hours in Canada, this continues to speak to the power and credibility of the IM HealthScience robust scientific body of evidence,” Alicja Wojewnik, CEO and founder of Dicentra, who led the IM HealthScience initiative for the amendment to Health Canada for the IBgard market authorization, said in the release.

“IM HealthScience looks forward to sharing this important innovation in IBS with patients in Canada and around the world,” Epstein said in the release.

Disclosure: Epstein is an employee of IM HealthScience and Wojewnik is an employee of Dicentra.