BOCA RATON, Fla., Dec. 19, 2016 /PRNewswire/ -- IM HealthScience® (IMH) today announced favorable results from its Irritable Bowel Syndrome Safety Update at 12 Months (IBSSU-12), a real-world surveillance study reporting on the safety and tolerability profile of IBgard®. It is estimated 326,880 individual patients used the product since the beginning of the surveillance. No serious adverse events were reported. Additionally, the self-reporting rates and patterns of non-serious adverse events were low with only 285 patients reporting any adverse events. These events included dyspepsia, nausea, abdominal pain and diarrhea.
The IBSSU-12 captured and analyzed serious and non-serious adverse event reports for IBgard® over a 12-month period from October 5, 2015 to September 30, 2016.
"It is not common for a pharmaceutical-level, post-marketing safety monitoring study to be conducted for a medical food," said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®. "IM HealthScience® elected to undertake this study at least for the first 12 months and the emerging safety profile is very reassuring."
Dr. Epstein added, "Heartburn and anal burning are common side effects reported with older peppermint oil products. However, in IBSSU-12, there were only 4 reports of anal burning and 3 reports of gastroesophageal reflux disease (GERD), which is remarkably low."
IBgard® is a medical food specially formulated for the dietary management of IBS. IBgard® capsules contain solid state microspheres of 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, quickly and reliably to the small intestine, where its actions help manage IBS. 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 for the second consecutive year by an overwhelming margin.
Like all medical foods, IBgard® does not require a prescription, but 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.
The Irritable Bowel Syndrome Safety Update at 12 Months (IBSSU-12) is a real-world surveillance study reporting on the safety and tolerability profile of IBgard® among an estimated 326,880 individual 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 September 30, 2016. An analysis of the data by reviewers showed that there were no reported serious adverse events associated with the use of IBgard® during this time frame. Only 285 patients reported non-serious adverse events, many of which were consistent with commonly reported symptoms of IBS. The top-reported, non-serious adverse events were diarrhea (37), dyspepsia (33), abdominal pain (22), flatulence (20) and upper abdominal pain (16).
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