Label change for new Irritable Bowel Syndrome (IBS) product follows submission of safety and tolerability data from the IBSREST™ clinical trial
TORONTO and BOCA RATON, Fla., Aug. 6, 2015 /PRNewswire/ -- IM HealthScience® announced today that the peppermint oil cautionary labeling for gastroesophageal reflux disease (GERD) as a risk factor is no longer required and has been removed for IBgard®, its new, natural health product for Irritable Bowel Syndrome (IBS). IBgard® was first authorized for sale by Health Canada's Natural and Non-Prescription Health Products Directorate (NNHPD) on June 11, 2015.
This latest action was undertaken after a review of the safety and tolerability data from IBSREST™ (Irritable Bowel Syndrome Response Evaluation and Safety Trial). No GERD effects were seen in the IBgard® arm of this trial. The product's previous market authorization 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. Two additional efficacy claims regarding the action of IBgard® to help improve/relieve IBS symptoms within 24 hours were recently added to the market authorization in response to the review and no objection to scientific evidence provided to Health Canada.
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 a new, safe and effective option," said Dr. Michael Epstein, a leading U.S. gastroenterologist and Chief Medical Officer of IM HealthScience®. "As with all medicinal products, effects may vary and patients should consult with their doctors if they have questions."
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.
Basis for Authorization
An Amendment to the IBgard® market authorization received no objections from the NNHPD, resulting in the issuance of an updated license, which no longer requires cautionary labeling for gastroesophageal reflux. The evidence provided in support of this Amendment included the results of a pivotal clinical trial recently conducted in the United States. This IBSREST™ clinical 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.
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, "This lifting of peppermint oil cautionary labeling for gastroesophageal reflux continues to speak to the power and credibility of the IM HealthScience® robust scientific body of evidence for IBgard®."
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.
About Irritable Bowel Syndrome
Irritable Bowel Syndrome is a frustrating, under diagnosed and undertreated condition that irritates the bowel and can disrupt the digestion of food and absorption of nutrients. It affects an estimated 15-20 percent of the U.S. population and an estimated 18 percent of the Canadian population. People who have IBS often experience distressful digestive symptoms, some of which can be severe or unbearable. Abdominal pain, bloating and altered abdominal bowel habits are examples of these symptoms.
About IM HealthScience®
IM HealthScience® is a privately held company based in Boca Raton, Florida, that developed IBgard®. It was founded in 2010 by a team of highly experienced pharmaceutical research and development and management executives. The company is dedicated to developing products to address gastrointestinal issues where there is a high unmet need, including Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Ulcerative Colitis, and Crohn's Disease. The IM HealthScience® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST®). For more information, visit www.IBgard.com to learn more about IBgard®.
SOURCE IM HealthScience
For further information: Gail S. Thornton, West Mill Consulting, + 1-908-392-3420, Gail@westmillconsulting.com, James G. Modica, West Mill Consulting, +1-908-872-4919, Jim@westmillconsulting.com