This latest update to the IBgard market authorization allows for the following additional claims on the product label:
– helps improve/relieve symptoms of IBS within 24 hours,
– helps improve/relieve the intensity of symptoms of IBS within 24 hours.
Currently, no other Natural Health Product (NHP) has been licensed for the relief of IBS symptoms with a 24-hour onset of action. This product’s previous market authorization already includes use for the overall symptoms of IBS, specifically for improvement or relief of abdominal pain and discomfort, abdominal bloating and distension, and urgency of bowel movement.
IBS is a frustrating, under diagnosed and undertreated condition characterized by abdominal pain and abnormal bowel habits that affects an estimated five million Canadians. In fact, Canada has one of the highest rates of IBS in the world and it contributes to the most common causes of work and school absenteeism, as noted by the Canadian Digestive Health Foundation.
"Consumers suffering from Irritable Bowel Syndrome now have not only an effective option, but also the only option that has been shown to work within 24 hours," said Dr. Michael Epstein , a leading U.S. gastroenterologist and Chief Medical Officer of IM HealthScience.
IBgard utilizes a novel delivery system called Site Specific Targeting (SST) designed to deliver peppermint oil in the form of tiny microspheres quickly and reliably to the small intestine, considered to be the primary site of disturbance in IBS.
An amendment to the IBgard market authorization received no objections from the NNHPD, resulting in the issuance of an updated license with claims for relief of IBS symptoms within 24 hours. The evidence provided in support of this Amendment included the results of a pivotal clinical trial recently conducted in the United States.
This clinical trial, entitled IBSREST (Irritable Bowel Syndrome Response Evaluation and Safety Trial), was a randomized, placebo-controlled trial of IBgard at four sites across the United States.
This clinical trial showed unprecedented efficacy and safety for IBgard and was selected by a committee of gastroenterology experts for four poster sessions and one oral presentation at the plenary session during Digestive Disease Week (DDW), a premier gastroenterology meeting of the American Gastroenterological Association in Washington, D.C. , in May 2015.
This meeting is the largest gastroenterology meeting in the world with 15,000 attendees. A standing-room-only gathering heard this oral presentation on May 18, 2015 . At this presentation, the 24-hour onset of action of IBgard was discussed and commented upon by the gastroenterology experts during the meeting.
Alicja Wojewnik, Chief Executive Officer, and Founder of Dicentra, who led the IM HealthScience initiative for the Amendment to Health Canada for the IBgard market authorization said, "As the first licensed NHP 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."
IBgard was made available to doctors and patients in the U.S. in 2014. It is available in the digestive aisle as a non-prescription medical food in CVS/pharmacy and Walgreens stores in the U.S. Its use in the U.S. is for the dietary management of IBS under medical supervision.
Medical foods, while not requiring U.S. Food and Drug Administration (FDA) pre-approval, must comply with regulatory requirements related to their manufacturing and distribution.
"IM HealthScience looks forward to sharing this important innovation in IBS with patients in Canada and around the world," said Dr. Epstein.