First peppermint oil natural health product approved by Health Canada for the relief of IBS symptoms

IM HealthScience has announced that IBgard, the first peppermint oil natural health product for the relief of Irritable Bowel Syndrome (IBS) symptoms, has been approved by Health Canada's Natural and Non-Prescription Health Products Directorate (NNHPD).

The product's label 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, underdiagnosed and undertreated condition characterised 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 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,' said Dr Michael Epstein, a leading US gastroenterologist and Chief Medical Officer of IM HealthScience.

IBgard utilises a novel delivery system called Site Specific Targeting (SST) that's 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.

Basis for approval

The NNHPD, in granting this approval, reviewed 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 randomised, 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 of the annual meeting of the American College of Gastroenterology in Washington, DC, in May 2015.

Alicja Wojewnik, Chief Executive Officer, 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 was made available to doctors and patients in the US in 2014. It is available in the digestive aisle as a non-prescription medical food in CVS/pharmacy and Walgreens stores in the US. Its use in the US. is for the dietary management of IBS under medical supervision.

Medical foods, while not requiring US Food and Drug Administration (FDA) preapproval, 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.