Twenty-Four Month, Post-Marketing Safety Surveillance Data Presented At The American College Of Gastroenterology (ACG) Annual Meeting Further Confirms Favorable Safety And Tolerability Profile For IBgard®

PHILADELPHIA, Oct. 9, 2018 /PRNewswire/ -- IM HealthScience^® (IMH), innovators of medical foods, today presented favorable, post-marketing safety surveillance data for IBgard^®, a novel medical food containing a specially formulated delivery system of peppermint oil for the dietary management of IBS. IBgard delivers peppermint oil in solid-state, triple-coated, sustained-release microspheres to the small intestine using patented Site Specific Targeting (SST^®) technology. The real-world IBSSU24 (Irritable Bowel Syndrome Safety Update at 24 Months) study examined the safety and tolerability profile of IBgard during a 24-month period. It is estimated that 773,322 individual patients used IBgard during this two-year surveillance period.  

The results were presented by Michael Epstein, M.D., AGAF, FACG, one of the study authors, during ACG 2018, the American College of Gastroenterology's Annual Scientific Meeting and Postgraduate Course. Dr. Epstein is a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. ACG is the preeminent professional organization that works on delivering evidence-based health care to gastroenterology patients through scientific investigation, education, prevention and treatment.

No Serious Adverse Events Reported in IBSSU24 Study

An analysis of the 24-month, post-marketing safety surveillance data for IBgard showed that:

• No serious adverse events were reported.
• The self-reporting rates of non-serious adverse events were low, with 626 events received (from 507 patients), a 0.07% event rate.
• The most frequently reported, non-serious adverse events were abdominal pain/discomfort/ distension (65), diarrhea (59), dyspepsia (56), constipation (29), and throat irritation (27). This pattern was within the range of common symptoms in populations of IBS patients.
• No pattern of heartburn or anal burning was observed during the 24-month time frame.
• There were only seven reports of gastroesophageal reflux disease (GERD)/burning and just one report of anal paresthesia.

"The unique formulation of IBgard, with solid-state, triple-coated, sustained-release microspheres, was shown to facilitate efficacy and tolerability by targeting rapid delivery to the small intestine, thus minimizing the common tolerability challenges found with older, liquid-filled, 'burst technology' peppermint oil products," said Dr. Epstein. "In reconfirming the previous excellent safety profile seen at 12 months in IBSSU12, the results of IBSSU24 provide further real-world evidence of the promise of this product to help meet the unmet needs of IBS patients."

Increasing Evidence of the Safety and Efficacy of IBgard^®
The data presentation at the 2018 ACG meeting follows the June 2018 publication of a new monograph¹ on the Management of Irritable Bowel Syndrome (IBS) from the American College of Gastroenterology, which, as in the preceding (2014) monograph, continues to include peppermint oil as a credible and viable option for IBS. The 2018 monograph provides support for the type of formulation used in IBgard. For the first time, the monograph takes into account findings from the landmark clinical trial for IBgard: IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial).  In fact, IBSREST™ was referenced 5 times in the 2018 monograph and was listed among the two studies "with a low risk of bias.¹"

Additionally, the data presented at ACG 2018 on IBSSU24, the safety surveillance study on IBgard confirms the positive results from IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial). IBSREST™ was a randomized, double-blind, placebo-controlled, multicenter trial, which demonstrated that IBgard^® provided reduction in eight hallmark symptoms of IBS:²  abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation and gas or mucus. This reduction of symptoms was seen at 24 hours, and the benefit expanded at four weeks². This study was published in the February 2016 print edition of Digestive Diseases and Sciences, a prominent medical journal in the field of gastroenterology and hepatology, in an article entitled "A Novel Delivery System of Peppermint Oil is an Effective Therapy for Irritable Bowel Syndrome.²"

In addition to concurring results seen in IBSREST and IBSSU24, a third study, IBSACT, also showed concurring results.  IBSACT (IBS Adherence and Compliance Trial) was a real-world observational study of 285 patients who took IBgard.³ In IBSACT, there was a high level (85% or higher) of patient satisfaction. Also in IBSACT, 60.8% of the patients only needed 1 to 2 capsules per day.

Earlier support for the safety and efficacy of peppermint oil includes data published in 2014 in the Journal of Clinical Gastroenterology, entitled "Peppermint oil for the treatment of irritable bowel syndrome: a systematic review and meta-analysis" (Khanna et al, 2014),⁴ which aimed to assess the efficacy and safety of enteric-coated peppermint oil capsules, compared with placebo, for the treatment of active IBS. The journal article, which described a systematic review and meta-analysis of nine studies that evaluated 726 patients, concluded that "peppermint oil is a safe and effective short-term therapy for active IBS." The authors also stated that "peppermint oil was found to be significantly superior to placebo for global improvement of IBS symptoms and improvement in abdominal pain."  Heartburn, however, emerged as a side effect in the older formulations that were studied in Khanna et al.⁴ An additional meta-analysis study noted the challenge of heartburn in IBS patients.⁵ The Khanna study was one of two important studies^4,6 mentioned in the ACG IBS 2018 Monograph, which led to the conclusion by the panel developing the ACG IBS 2018 Monograph that enteric coated peppermint oil formulations in more distal delivery were needed to avoid this heartburn side effect.

IBgard's solid-state, triple-coated, sustained-release microspheres enable it to provide more distal delivery.

About IBSSU24
The IBSSU24, (Irritable Bowel Syndrome Safety Update at 24 Months) was a real-world surveillance study reporting on the safety and tolerability profile of IBgard among an estimated 773,322 individual patients who used the product. An independent call center with pharmacovigilance-trained 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, 2017. 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 626 non-serious adverse events were received. The top-reported, non-serious adverse events were abdominal pain/discomfort/distension (65), diarrhea (59), dyspepsia (56), constipation (29), flatulence (27), and throat irritation (27). This pattern was within the range of common symptoms in populations of IBS patients.

More importantly, IBgard's more distal delivery advantage was further validated due to no pattern of heartburn seen in among the more than 700,000 patients in IBSSU24.

About IBgard^®
IBgard® is a medical food specially formulated for the dietary management of IBS. IBgard capsules contain solid-state, triple-coated, sustained-release microspheres of peppermint oil, 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 ultra-purified peppermint oil, quickly and reliably to the small intestine, where its sustained-release action in the entire small intestine further helps manage IBS. The food nutrients in IBgard (peppermint oil along with fiber and amino acids) may help reduce the low-grade, 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.

IBgard previously was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial: IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial).  Patients suffering from IBS-M and IBS-D were included in the study. The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal. The data showed that IBgard demonstrated a statistically significant reduction in the Total IBS Symptom Score (TISS) in as early as 24 hours and the benefit grew at four weeks. The TISS represents a composite score of eight individual IBS symptoms.

In addition to concurring results seen in IBSREST and IBSSU24, a third study, IBSACT also showed concurring results.

IBSACT, a real-world observational study of 285 patients who took IBgard, showed a high level (85% or higher) of patient satisfaction. 60.8% of the patients needed only needed 1 to 2 capsules per day.

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard for their patients.

For the third consecutive year, IBgard continues to be "#1 recommended" for IBS among gastroenterologists nationwide.^†

Like all medical foods, IBgard does not require a prescription but it must be used under medical supervision. The usual adult dose of IBgard is, when in flare, 2 capsules, 3 times a day, 30-90 minutes before meals, for 4 weeks,*and for maintenance (i.e., daily and proactive gut-health support), 2 capsules, once a day, 30-90 minutes before a meal.**  The maximum dose is 8 capsules  per day.

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 independent drug stores and grocery stores across the country.

About the American College of Gastroenterology
Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 14,000 individuals from 85 countries. The College's vision is to be the preeminent professional organization that champions the evolving needs of clinicians in the delivery of high-quality, evidence-based and compassionate health care to gastroenterology patients. The mission of the College is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation and advocacy in the areas of scientific investigation, education, prevention and treatment. Follow ACG on Twitter @AmCollegeGastro and on the web at www.gi.org.

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^®, 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.

Visit IM Health Science at booth 917 to learn more about IBgard.
Data Presented at ACG 2018 Poster Session on Monday, October 8, 2018, 1-2:15pm

• (Supplement 454, Poster P1232) 24-Month Post Marketing Safety Surveillance Data of a Novel Peppermint Oil Formulation for IBS Designed for Site Specific Targeting (PO-SST), Confirms Favorable Safety Profile, Including Heartburn and Anal Burning
• Michael Epstein, MD, AGAF, FACG, Syed Shah, PhD, Patrick Corsino, PhD.

References

1. Ford AC, Moayyedi P, Chey WD, et al. American College of Gastroenterology Monograph on the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 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. Dig Dis Sci. 2016;61(2):560-571. doi:10.1007/s10620-015-3858-7.
3. 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. Int J Dig Dis. 2016;2(2):1-5. doi:10.4172/2472-1891.100027.
4. Khanna R, MacDonald JK, Levesque BG. Peppermint Oil for the Treatment of Irritable Bowel Syndrome: A Systematic Review and Meta-analysis. J Clin Gastroenterol. 2014;48(6):505-512. 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. J Ethnopharmacol. 2016;194(November):937-946. doi:10.1016/j.jep.2016.10.083.
6. Lovell RM, Ford AC. Prevalence of gastro-esophageal reflux-type symptoms in individuals with irritable bowel syndrome in the community: A meta-analysis. Am J Gastroenterol. 2012;107(12):1793-1801. doi:10.1038/ajg.2012.336.

*Primarily based on IBSREST
**Primarily based on IBSAC
^† Among Gastroenterologists recommending peppermint oil for IBS. 2017 ProVoice survey.

This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. You should not use this information for diagnosing a health problem or disease. Only physicians can diagnose IBS. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.IBgard.com. Individual results may vary.

SOURCE IM HealthScience

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