New non-prescription product uses patented technology to manage IBS symptoms
MONTREAL, Oct. 24, 2016 /CNW/ - Today IM HealthScience®, announced the availability of IBgard®, a new natural health product for IBS - a condition that affects more than five million Canadians.i The first of its kind in Canada, non-prescription IBgard® uses an innovative targeted technology to deliver peppermint oil directly to the small intestine, where IBS sufferers need it most.ii
"With more than 120,000 Canadians developing IBS each year, this is a therapeutic area that requires more treatment options," said Dr. Albert Cohen, a Gastroenterologist at Sir Mortimer B. Davis-Jewish General Hospital. "IBgard® presents my current and future patients with more treatment options to combat the distressing symptoms that IBS sufferers live with, such as severe abdominal pain, bloating, diarrhea and constipation."
IBgard® capsules contain individually triple-coated, sustained-release, microspheres of Ultramen®, an ultra-purified peppermint oil. Peppermint oil and its principal component
l- Menthol, has a history of effectiveness in IBSiii. However, until now, its targeted delivery to the lower gut has posed a challenge. Only IBgard® utilizes the breakthrough science of SST® (Site Specific Targeting) technology, to deliver microspheres of peppermint oil (in a solid state) to the lower gut.iv
"We are excited and proud to be launching IBgard® in Canada as there exists a high unmet medical need for more options for people suffering from this condition," indicated Stéphane Langevin General Manager Canada. "IBgard® is effective and well tolerated; in its first year of availability in the U.S., it quickly became the # 1 peppermint oil recommended for IBS by U.S. gastroenterologists," added Mr. Langevin.
In a pivotal 4 week randomized double blind, placebo controlled, multicenter clinical trial conducted in the U.S. called the Irritable Bowel Syndrome Reduction Evaluation and Safety Trial (IBSREST), IBgard® significantly reduced the Total IBS Symptom Score (TISS) in as early as 24 hours and at four weeks in a combined group of mixed diarrhea and constipation (IBS-M) and diarrhea predominant (IBS-D) patients.v Specifically IBgard®:
- Reduced the total mean score of frequency and intensity of eight measured symptoms of IBS: abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation, and gas or mucus;vi
- Reduced abdominal pain or discomfort at 24 hours and four weeks;vii
- Is well tolerated with side effects comparable to placebo.viii
According to Brooks D. Cash, Professor of Medicine in the Gastroenterology Division at the University of Alabama in Mobile, "the IBSREST study was designed to answer a very important scientific question about the effectiveness, safety, and tolerability of a novel formulation of peppermint oil for managing symptoms of IBS. IBgard® was found to be effective, safe and well tolerated".
In a post-study assessment:
- 88.3 per cent of patients noted "moderate" or "major" overall improvement in IBS symptoms and quality of life;ix
- 88.3 per cent were likely or very likely to continue taking IBgard®;x
- 94.1 per cent would likely or very likely recommend IBgard® to family or friends who have IBS symptoms.xi
IBgard® is entering the Canadian market at a time when the annual economic and national healthcare burden of IBS is in excess of $6.5 billion, not including over-the-counter drugs and prescriptions.xii Current acute care inpatient costs for IBS are ranked as Canada's fourth most-expensive digestive disease.xiii In addition, a patient with unmanaged IBS misses an average of 13 work days a year, resulting in an indirect cost of $8 billion in productivity loss a year.xiv IBgard® is now available in the digestive aisle in pharmacies nationwide.
About IM HealthScience®
IM HealthScience® (IMH) is the innovator of IBgard® a natural health product for irritable bowel syndrome (IBS). It is a privately held company based in Boca Raton, Florida. 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. 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.imhealthscience.com to learn about the company, or www.IBgard.ca.
i Canadian Digestive Health Foundation. Understanding Irritable Bowel Syndrome (IBS). Accessed June 2016. Available at: http://cdhf.ca/bank/document_en/15understanding-irritable-bowel-syndrome-ibs-.pdf#zoom=100
ii Digenis, G.A. et al The in vivo behavior of multiparticulate versus single unit dose formulations. Capsugel Library. Presented at the CAPSUGEL's Symposium in Seoul; 1-16, (April 10, 1990)./ Kellow, J.E., et al. Altered small bowel motility in irritable bowel syndrome is correlated with symptoms. Gastroenterology. 1987 Jun;92(6):1885-93. / Dunlop, S.P., et al. Abnormal Intestinal Permeability in Subgroups of Diarrhea-Predominant Irritable Bowel Syndromes. Am J Gastroenterol. 2006 Aug;101(8):1944.
iii Khanna, R , et, al. Peppermint Oil for the treatment of Irritable Bowel Syndrome, A systematic Review and Meta-Analysis. Journal of Clinical Gastroenterology 2014 Vol. 48, Number 6: 505-512.
v Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Digestive Diseases and Sciences 2016; Vol 61: 550-571.
vi Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Digestive Diseases and Sciences 2016; Vol 61: 563.
vii Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Digestive Diseases and Sciences 2016; Vol 61: 550-571.
viii Cash BD, Epstein MS, Shah SM. A Novel Delivery System of Peppermint Oil Is an Effective Therapy for Irritable Bowel Syndrome Symptoms. Digestive Diseases and Sciences 2016; Vol 61: 550-571.
ix IBSREST Clinical Study report, Data on file, IM HealthScience.
xii Canadian Digestive Health Foundation. Understanding Irritable Bowel Syndrome (IBS). Accessed June 2016. Available at: http://cdhf.ca/bank/document_en/15understanding-irritable-bowel-syndrome-ibs-.pdf#zoom=100
xiii Canadian Digestive Health Foundation. Establishing Digestive Health as A Priority for Canadians. Accessed June 2016.Available at: http://www.cdhf.ca/bank/document_en/25establishing-digestive-health-as-a-priority-for-canadians.pdf
SOURCE IM HealthScience
For further information: Media Contacts: Eric MacDonald, Weber Shandwick Toronto, EMacDonald@webershandwick.com, (416) 642-7951; Anabelle Gendron-Turcotte, Weber Shandwick Montreal, AGendron-Turcotte@webershandwick.com, (514) 447-3936