New Real-World Data From Surveillance Study Confirms Excellent Safety And Tolerability Profile Of IBgard®
BOCA RATON, Fla., Aug. 29, 2016 /PRNewswire/ -- IM HealthScience® (IMH) today announced favorable results from its Irritable Bowel Syndrome Safety Update at 6 Months (IBSSU-6), a real-world surveillance study reporting on the safety and tolerability profile of IBgard® among an estimated 163,165 patients who used the product. The results found no serious adverse events. Additionally, the rates and patterns of non-serious adverse events were low (0.05 percent or 89 people out of 163,165 patients studied) and generally consistent with those normal adverse events commonly associated with an IBS population. These non-serious adverse events included dyspepsia, nausea, abdominal pain and diarrhea.
The IBSSU-6 captured and analyzed serious and non-serious adverse event reports for IBgard® over a six-month period from October 5, 2015 to May 31, 2016.
"Real-world research is a vital component to clinical trials and helps with defining management options for patients," said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®. "The findings from IBSSU-6 reaffirm the safety and tolerability profile of IBgard® in real-world settings and show the use of IBgard is consistent with the adverse events reported in our landmark clinical trial, IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial)."
Dr. Epstein added, "Heartburn and anal burning are common side effects associated with older peppermint oil products. However, in IBSSU-6, there were no reports of anal burning and reports of heartburn were remarkably low, no different than what physicians see as existing co-morbid conditions in the patient population suffering from IBS."
About IBgard IBgard® capsules contain peppermint oil, including its principal component l-Menthol, in a unique delivery system. With its patented Site Specific Targeting (SST®) technology, pioneered by IM HealthScience®, IBgard® capsules release Ultramen®, an ultra-purified peppermint oil, in the small intestine. Peppermint oil can help toward normalizing the digestion of food and the absorption of nutrients, which have been compromised by IBS. Peppermint oil has also been shown to normalize intestinal transit time.
Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard® for their patients. In a recent nationwide survey of gastroenterologists, IBgard® was the number one recommended peppermint oil for IBS. While IBgard® does not require a prescription, it must be used under medical supervision. Only doctors can diagnose IBS. The usual adult dose of IBgard® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day.
IBgard® is available to patients in the digestive aisle at most CVS/pharmacy, Walgreens and Rite Aid stores nationwide and now increasingly in independent drug stores and grocery stores across the country.
About IBSSU-6The Irritable Bowel Syndrome Safety Update at 6 Months (IBSSU-6) is a real-world surveillance study reporting on the safety and tolerability profile of IBgard® among an estimated 163,165 patients who used the product. An independent call center was retained to train personnel on properly reporting events and to receive and record IBgard® customer questions, product issues and adverse events. The adverse events for this study were collected and processed from October 5, 2015 to May 31, 2016. An analysis of the data by reviewers showed that there were no serious adverse events associated with the use of IBgard® during this time frame. Only 89 patients reported non-serious adverse events, out of an estimated 163,165 patients who used IBgard® during this period. The adverse event rate of 0.05% was low and the reviewers believed it was difficult to separate these adverse events from the normal adverse events commonly associated with an IBS population.
About IM HealthScience®IM HealthScience® (IMH) is the innovator of IBgard® for the dietary management of irritable bowel syndrome. It is a privately held company based in Boca Raton, Florida, that is also the innovator of FDgard® for the dietary management of functional dyspepsia. 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.com or www.FDgard.com.
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SOURCE IM HealthScience