First-Ever 36 Month Real-World, Post-Marketing Surveillance Study Confirms The Excellent Safety And Tolerability Profile Of IBgard®, A Non-Prescription Product For IBS

- Irritable Bowel Syndrome Safety Update at 36 months (IBSSU36) reconfirms the excellent safety and tolerability profile of IBgard® previously seen at 24 months¹

- No pattern of  heartburn was seen with IBgard, which clearly separates it from conventional peppermint oil products^2, §§   

- No serious adverse events for IBgard reported over the 3 year monitoring period

- IBgard is a clinically studied, nonprescription medical food for the dietary management of Irritable Bowel Syndrome (IBS)

BOCA RATON, Fla., Aug. 7, 2019 /PRNewswire/ -- IM HealthScience^® (IMH) today announced favorable results from the longest-running post-marketing surveillance study of its type. This study called Irritable Bowel Syndrome Safety Update at 36 Months (IBSSU36), is a real-world surveillance study reporting on the safety and tolerability profile of IBgard^®. It is estimated that 2.48 million individual patients used the product since the beginning of this surveillance. No serious adverse events were reported. Additionally, no significant pattern of non-serious adverse events emerged. The fact that the earlier post-marketing safety update at 24 months¹ supports the same benign safety and tolerability profile of IBgard, provides conclusive evidence on its safety and tolerability. Also, importantly, no significant pattern of heartburn was observed. In the American College of Gastroenterology 2018 IBS Monograph, heartburn was noted as a side effect of conventional peppermint oil preparations.²

The IBSSU36 study captured and analyzed serious and non-serious adverse event reports for IBgard over a 36-month period from October 5, 2015, to October 5, 2018.

"Such a long and comprehensive post-marketing safety study for a nonprescription product is very rare," said Michael S. Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. "The findings from IBSSU36 conclusively reaffirm the safety and tolerability profile of IBgard in real-world settings. In fact, it may be difficult to separate the scatter of the events from background noise associated with the IBS population."

Dr. Epstein added, "In the American College of Gastroenterology 2018 IBS Monograph, heartburn had been singled out as an issue among conventional peppermint oil products.² It is gratifying to note that IBgard's more distal delivery technology helped avoid any significant pattern of heartburn, even after 36 months."

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 2.48 million 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 October 5, 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. Only 885 non-serious adverse events were received, many of which were consistent with commonly reported symptoms of IBS. The top-reported, non-serious adverse event was diarrhea. Since diarrhea is a very common presenting symptom in IBS (up to 95% of IBS patients)³, it is difficult to assign this as causation by the product.

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 ultra-purified peppermint oil, quickly and reliably to the small intestine, where its actions help 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 also been shown to help normalize intestinal transit time.

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. The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal.^4, †† 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.⁵

Additionally, results from a real-world observational study of 285 patients who took IBgard, called IBSACT™ (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.^6,§

Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during flare-ups.

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 IBS⁷ among gastroenterologists nationwide by an overwhelming margin.

Like all medical foods, IBgard does not require a prescription, but it must be used under medical supervision. Only a physician can diagnose 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.

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.

1. Epstein M, Shah S, Corsino P. 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. In: American College of Gastroenterology Annual Conference. Philadelphia, PA; 2018.
   
2. Ford AC, Moayyedi P, Chey WD, et al. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2018:S1-S18. doi:10.1038/s41395-018-0084-x
   
3. Hungin APS, Chang L, Locke GR, Dennis EH, Barghout V. Irritable bowel syndrome in the United States: Prevalence, symptom patterns and impact. Aliment Pharmacol Ther. 2005;21(11):1365-1375. doi:10.1111/j.1365-2036.2005.02463.x
   
4. 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
   
5. 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. Dig Liver Dis. 2007;39:530-536.
   
6. 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
   
7. 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. Dig Dis Sci. 2016;61(2):560-571. doi:10.1007/s10620-015-3858-7.

^§IBSACT™ (IBS Adherence and Compliance Trial), a real-world, patient-reported outcomes trial published in a peer-reviewed 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. Int J Dig Dis. 2016;2(2):1-5.

^§§Also based on yet another study with results that concurred with prior studies was IBSSU24 (IBS Safety Update at 24 months), announced via an IMH press release on April 19, 2018. In IBSSU24, the real-world evidence in over 700,000 estimated users pointed to no pattern of any adverse events (including no pattern of heartburn, a common adverse event seen in older liquid-filled peppermint oil technologies.) https://www.prnewswire.com/news-releases/real-world-data-from-surveillance-study-confirms-excellent-safety-and-tolerability-profile-of-ibgard-at-24-months-300633166.html.

^† Individual results may                         

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 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. Health care practitioners should use their independent, professional judgement 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.

SOURCE IM HealthScience

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