MEDICAL BULLETIN BOARD

Three-year Safety Data Analysis Indicates No Pattern of Heartburn with Ibgard®

June 2020 • Volume XLIV, Issue 6

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Data from a 36-month, real-world, post-marketing study confirming the safety profile of IBgard® (PO-SST), a novel peppermint oil product in patented solid-state microspheres, is now available for review on the DDW e-poster website.

• In one of the longest-running post-marketing surveillance studies of its kind, involving an estimated 2.4 million users, data showed that IBgard® is a safe and well-tolerated option for managing IBS.

• No pattern of heartburn was seen with IBgard®. As noted in the 2018 American College of Gastroenterology (ACG) IBS Monograph1 , among older, liquid-filled, “burst technology” peppermint oil products, heartburn is a common side effect. The 2018 ACG IBS Monograph called for a more distal delivery of peppermint oil.

• IBgard®, with its novel, triple-coated microsphere technology, provides more distal delivery by avoiding release in the stomach, by targeting the small intestine, and by then releasing over 4 hours.5 It thus avoids the problems of older PO products, particularly heartburn.

BOCA RATON, Fla. – IM HealthScience® (IMH) today announced that the Irritable Bowel Syndrome Safety Update at 36 months (IBSSU36) study is now available for review as an e-poster on the Digestive Disease Week® (DDW) e-poster and e-paper web site:

https://ddw.apprisor.org/epsAbstractDDW.cfm?id=1

The peer-reviewed and published e-poster is titled, “36 MONTH SURVEILLANCE DATA CONFIRMS SAFETY PROFILE OF A NOVEL PEPPERMINT OIL FORMULATION FOR IBS (PO-SST).”

IBSSU36 is a real-world safety surveillance study reporting on the safety and tolerability profile of IBgard® and was conducted to determine if any issues, including heartburn or anal burning, were surfacing as a side effect. In the American College of Gastroenterology 2018 IBS Monograph, heartburn was noted as a side effect of conventional peppermint oil preparations.1 In the same 2018 Monograph, it was noted that heartburn is an issue because the IBS population has four times the heartburn as the general population.3 The authors of the study poster note that older, liquid-filled, burst technology peppermint oil products showed that as high as 26 to 29.7% of patients experience adverse events (AEs), heartburn being the most common.4,5 A key finding of this study is that no pattern of heartburn or anal burning was observed during the 36-month timeframe with IBgard®.

Commenting on the findings of the study, Brian Lacy, M.D., PhD, FACG, a leading gastroenterologist at the Mayo Clinic and the lead author of the study, said, “We know that peppermint oil improves the symptoms of IBS, but many older peppermint oil products can cause unwanted side effects, such as heartburn. IBgard®, with its targeted delivery to the small intestine, was shown in this study to avoid any pattern of heartburn or anal burning, even after 36 months and an estimated 2.4 million patients had taken the product.”

The 3-year data safety analysis also confirmed that no reports of serious adverse events and no significant pattern of non-serious adverse events had emerged. It is estimated that over 2.4 million individual patients used the product during the three-year surveillance period of October 5, 2015, to September 30, 2018.

“We are gratified that this important postmarketing study has been peer-reviewed and then published via a poster on the DDW website,” said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. “It is important for health care professionals and patients to be aware of the excellent safety and tolerability profile of IBgard®.”

About IBSSU36

The Irritable Bowel Syndrome Safety Update at 36 Months (IBSSU36) is a real-world surveillance study reporting on the safety and tolerability profile of IBgard® among an estimated 2.4 million individual patients who used the product. An independent call center with pharmacovigilancetrained health care personnel in accordance with U.S. Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events was retained 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, 2018. 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.

About IBgard®

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, plus fiber and amino acids (from gelatin protein), in a unique delivery system.

With its patented Site-Specific Targeting (SST®) technology pioneered by IM HealthScience, IBgard® capsules release Ultramen®, an ultrapurified peppermint oil, quickly and reliably to the small intestine, where it is designed to release over 4 hours in a sustained release manner.2 The food nutrients in IBgard® (peppermint oil along with fiber and amino acids) may help reduce the low-grade, localized, often temporary, reversible inflammation found in some IBS patients and help normalize gut mucosal barrier function. Additionally, peppermint oil has been shown to help normalize intestinal transit time.6

IBgard® previously was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called IBSREST™ †† (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial). Patients suffering from IBS-D and IBS-M (alternating IBS-C and IBS-D) were included in the study. This important study was presented at DDW in May 2015 to a standing-room-only audience. The study findings were accepted after peer review and then published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peerreviewed scientific journal.2,†† The data showed that IBgard® demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours and at four weeks. The TISS represents a composite score of eight individual IBS symptoms.7 In a secondary analysis, IBgard® also showed efficacy among IBS-M patients.8 IBS-M has been observed to represent up to 74% of IBS patients.9,†

Additionally, results from a real-world observational study of 285 patients who took IBgard®, called IBSSACT™ †† (Irritable Bowel Syndrome Adherence and Compliance Trial), showed that there was a high level of patient satisfaction with the product even among those patients taking several capsules on a daily basis. One out of two IBS patients taking IBgard® needed only 1 to 2 capsules per day to obtain individualized relief from IBS symptoms. In addition, 75 percent of the patients felt relief of abdominal pain, discomfort and/or bloating within 2 hours, while 95 percent of patients reported relief within 24 hours after taking IBgard®. 10,†

Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during flare-ups. Also, no Rx drug has been approved for IBS-M.

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard® for their patients. For five consecutive years, IBgard® continues to be the #1 recommended peppermint oil for IBS among gastroenterologists nationwide by an overwhelming margin.11

Like all medical foods, IBgard® does not require a prescription, but it must be used under medical supervision. Only a physician can confirm suspected IBS. Many physicians are now recommending taking IBgard® 30-90 minutes before a meal, as it enables the supportive effect of IBgard® to start as early as possible.

IBgard® is available to patients in the digestive aisle at most Walmart, Target, CVS/pharmacy, Walgreens, and Rite Aid stores nationwide as well as in grocery stores across the country and on Amazon.

About IM HealthScience®

IM HealthScience® (IMH) is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. The sister subsidiary of IMH, Physician’s Seal®, also provides REMfresh®, a well-known continuous release and absorption melatonin (CRA-melatonin) supplement for sleep. IMH 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 overall health and wellness, including conditions with a high unmet medical need, such as digestive health. 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®, www.FDgard.com, www.FiberChoice.com, and www.REMfresh.com.

About Digestive Disease Week®

Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers, and academics in the fields of gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW 2020 was scheduled for May 2-5, 2020, in Chicago, but was canceled due to COVID-19 and the nationwide lockdown. More information can be found at www.ddw.org.

  1. Ford AC, Moayyedi P, Chey WD, et al. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. The American Journal of Gastroenterology. 2018:S1–S18. doi:10.1038/s41395-018-0084-x.
  2. 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;61(2):560-571. doi:10.1007/s10620-015-3858-7.
  3. Lovell RM, Ford AC. Prevalence of gastro-esophageal reflux-type symptoms in individuals with irritable bowel syndrome in the community: A meta-analysis. American Journal of Gastroenterology. 2012;107(12):1793-1801. doi:10.1038/ajg.2012.336.
  4. Khanna R, MacDonald JK, Levesque BG. Peppermint Oil for the Treatment of Irritable Bowel Syndrome: A Systematic Review and Meta-analysis. Journal of clinical gastroenterology. 2014;48(6):505-doi:10.1097/MCG.0b013e3182a88357.
  5. Mosaffa-Jahromi M, Lankarani KB, Pasalar M, Afsharypuor S, Tamaddon AM. Efficacy and safety of enteric coated capsules of anise oil to treat irritable bowel syndrome. Journal of Ethnopharmacology. 2016;194(November):937-946. doi:10.1016/j.jep.2016.10.083.
  6. Goerg KJ, Spilker T. Effect of peppermint oil and caraway oil on gastrointestinal motility in healthy volunteers: A pharmacodynamic study using simultaneous determination of gastric and gall-bladder emptying and orocaecal transit time. Alimentary Pharmacology and Therapeutics. 2003. doi:10.1046/j.1365-2036.2003.01421.x.
  7. Cappello G, Spezzaferro M, Grossi L, Manzoli L, Marzio L. Peppermint oil (Mintoil) in the treatment of irritable bowel syndrome: A prospective double blind placebo-controlled randomized trial. Digestive and Liver Disease. 2007;39:530-536.
  8. Cash BD, Epstein MS, Shah S. Peppermint Oil with Site Specific Targeting is an Effective Therapy for Irritable Bowel Syndrome with Mixed Bowel Habits. Internal Medicine Review. 2017;3(9):1-20.
  1. Hungin APS, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: Prevalence, symptom patterns and impact. Alimentary Pharmacology and Therapeutics. 2005;21(11):1365-1375. doi:10.1111/j.1365-2036.2005.02463.x.
  2. Cash BD, Epstein MS, Shah SM. Patient satisfaction with IBS symptom relief using a novel peppermint oil delivery system in a randomized clinical trial and in the general population. International Journal of Digestive Diseases. 2016;2(2):1-5. doi:10.4172/2472-1891.100027.
  3. IQVIA. ProVoice Survey IBgard Is the #1 Gastroenterologist Recommended Peppermint Oil For Patients with IBS; 2019 [Among gastroenterologists who recommended peppermint oil for IBS]. ††Based on IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial), a randomized, placebo-controlled trial in 72 IBS patients. Patients taking IBgard on a daily and proactive basis experienced a statistically significant reduction versus placebo in the total IBS symptoms score (TISS), including abdominal pain and discomfort, at 24 hours, with continued and expanding benefits at 4 weeks. Cash BD, Epstein MS, Shah SM. A novel delivery system of peppermint oil is an effective therapy for irritable bowel syndrome symptoms. After peer review, published in Dig Dis Sci. 2016;61(2):560-571. doi:10.1007/ s10620-015-3858-7. §IBSSACT™ (Irritable Bowel Syndrome Adherence and Compliance Trial), a real-world, patient-reported outcomes trial published in a peerreviewed journal, showed IBgard efficacy in 1-2 hours. Cash BD, Epstein MS, Shah SM. Patient satisfaction with IBS symptom relief using a novel peppermint oil delivery system in a randomized clinical trial and in the general population. After peer review, published in Int J Dig Dis. 2016;2(2):1-5. †Individual results may vary. IBgard is protected by U.S. patents No: 8,808,736; 9,192,583; 9,393,279; 9,572,782; 9,707,260; 9,717,696; and 8,895,086. Additional patents are pending in the United States and other jurisdictions. Daily Gut-Health Gard™ is pending approval for a registered trademark of IM HealthScience. Calms the Angry Gut® is a registered trademark of IM HealthScience. Copyright © 2019 IBgard®. The information provided here is for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professional. This information should not be used for diagnosing a health problem or disease. While medical foods do not require prior approval by the FDA for marketing, they must comply with regulations. It should not be assumed that medical foods are alternatives for FDA-approved drugs. Only doctors can definitively diagnose IBS. Use under medical supervision. Statements made in this release rely upon reviews of literature, input from IMH’s advisors, and IMH’s own expertise. There may always be other opinions or emphasis points. Some of the statements from different sources may not mesh with each other. There may be inadvertent inaccuracies that IMH is not aware of. There may be disparate views on the complex pathophysiology of FGIDs (Functional Gastrointestinal Disorders) and on diagnosis and treatment guidelines. Space limitations in this release only allow limited reference to some guidelines or practices which may or may not be fully agreed to by all scientific, medical, or regulatory experts. For any of IMH’s products, this release does not make or have any intent to make drug claims or any comparison or implied claims against FDA approved interventions for IBS-D and IBS-C. Any comments on any products are based on literature reviews and input from IMH’s own advisors. There may be others who have other points of view. Pre-clinical findings do not always correlate with clinical or real-world findings. The reader is urged to check all current information, including the latest website disclosures and/or package inserts, of any of the medical products mentioned here, as information, including government regulations, changes all the time. The statements of individual opinions are those of the individuals quoted and do not necessarily reflect the opinions of IMH. Please fully read all disclaimers/clarifications/ explanations. IMH disclaims any injury or alleged injury resulting from any ideas, methods, instructions, or products referred to here. Healthcare practitioners should use their independent, professional judgment in helping their patients best manage their FGID conditions. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the latest information on IBgard can be found on the website.

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