For The Sixth Year In A Row, In A Survey Of Gastroenterologists' Preferences For IBS Products, IBgard® Widens Its Already Preeminent "#1 Recommended"[1] Status

BOCA RATON, Fla., Aug. 10, 2020 /PRNewswire/ -- IM HealthScience^®, innovators of medical foods and dietary supplements, today announced the results of a high-quality, nationwide survey conducted among a representative and projectable sample of U.S. gastroenterologists, which again confirmed IBgard's^® "#1 Recommended"¹ rating. IBgard is a specially formulated nonprescription medical food for the daily dietary management of IBS^§. It incorporates a unique, patented delivery system. 

The widespread acceptance of IBgard is confirmed by the results of this survey. For the sixth consecutive year, IBgard is the #1-recommended peppermint oil product for IBS and is by far the leader in its own market segment with 83% of physician recommendations.¹  Additionally, and for the first time, physicians also indicate a broader preference for IBgard for digestive issues, with 80% of gastroenterologists recommending within IBgard's market segment.⁶

IBgard benefits from a unique, patented, solid-state, triple-coated, microsphere-based technology. This technology enables solid-state microspheres carrying entrapped peppermint oil to rapidly transit intact through the stomach. By avoiding the release of peppermint oil in the stomach, heartburn is avoided. These same microspheres are then designed to be released beyond the stomach, in a more distal delivery, over 4 hours to help coat the entire small intestine.^2,3

This type of more distal delivery was recommended in the 2018 American College of Gastroenterology Monograph on IBS.⁷ In this same Monograph, conventional peppermint oil products were associated with heartburn as a side effect.^7?9 This Monograph also highlighted that heartburn is a relevant concern as the IBS population already has four times as much heartburn as the general population.^7,10

"IBgard continues to increase its already broad professional recommendation base because health care practitioners continue to receive very positive feedback from the patients who receive their recommendations for IBgard," said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor of IM HealthScience. He continued, "This real-world patient feedback, coupled with compelling scientific data, ^2?4 is why IBgard has become such a popular mainstay not only in the management of IBS, a difficult-to-treat condition, but also for other digestive issues as well."

About Irritable Bowel Syndrome
One in six Americans experiences Irritable Bowel Syndrome (IBS), a frustrating, underdiagnosed, and undertreated condition characterized by recurrent abdominal pain^?, often associated with alteration in stool frequency and/or form^?.^11,12 Bloating^? is another common symptom experienced by patients with IBS. This relapsing-remitting disorder typically needs daily and proactive management over a long period since up to 70% of patients continue to experience symptoms, even after 10 years.¹² Recent understanding regarding the multiple etiologies of IBS points to gut mucosal barrier dysfunction associated with reversible, often temporary, low-grade, localized inflammation as a potential contributor to abdominal pain and accompanying symptoms.¹³

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 are designed to contain these peppermint oil-carrying solid-state, triple-coated, microspheres and to have them move intact rapidly through the stomach and then to release the peppermint oil from the microspheres in a broad-brush manner over 4 hours^2,3 in the entire small intestine. The food nutrients in IBgard (peppermint oil along with fiber and amino acids) may help normalize gut mucosal barrier function. Additionally, peppermint oil has been shown to help normalize intestinal transit time.¹⁴

IBgard previously was studied in a pivotal, randomized, placebo-controlled, double-blinded, multi-center trial called IBSRESTtm² (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, the world's premier annual gastroenterology meeting, 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, peer-reviewed 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.¹⁵ In a secondary analysis, IBgard also showed efficacy among IBS-M patients.⁴ IBS-M has been observed to represent up to 74% of IBS patients.¹¹
Additionally, results from a real-world observational study of 285 patients who took IBgard, called IBSACTtm³ (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 patients taking IBgard needed only 1 to 2 capsules per day to obtain individualized relief from IBS symptoms. In addition, 75% of patients felt relief of abdominal pain, discomfort and/or bloating within 2 hours, while 95% of patients reported relief within 24 hours after taking IBgard.³

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 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, 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 and there was no pattern seen among the other reported events in this large population set.⁵

Another indicator of patient satisfaction with IBgard is the high repeat purchase rate.¹⁶

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.

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. By reducing anticipatory anxiety related to digestive issues, IBgard, as a Daily Gut-Health Gard, provides the Shield of Confidence®. The usual adult dose for IBgard, when in flare, is 2 capsules three times per day, and for daily and proactive gut health support, two capsules once a day.

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

About IQVIA ProVoice Survey
ProVoice has the largest sample size of any professional healthcare survey in the U.S., with nearly 60,000 respondents across physicians, nurse practitioners, physician assistants, optometrists, dentists, and hygienists, measuring recommendations across more than 120 over-the-counter categories. Manufacturers use ProVoice for claim substantiation, promotion measurement, and HCP targeting.

IQVIA fielded a survey in July 2019 ? April 2020 among 302 U.S. gastroenterologists for IM HealthScience. The ProVoice survey methodology validated the claim, at a 99% confidence level, that for the sixth consecutive year, "IBgard^® is the #1 gastroenterologist-recommended peppermint oil for patients with Irritable Bowel Syndrome (IBS)."

A second survey was conducted in June 2020 among 74 gastroenterologists for IM HealthScience. The ProVoice survey methodology validated the claim, at a 99% confidence level, that "IBgard is the #1 gastroenterologist-recommended peppermint oil for digestive issues."

About IM HealthScience®
IM HealthScience^® (IMH) is the innovator of IBgard^® and FDgard^® for the dietary management of IBS and FD (Functional Dyspepsia: meal-triggered indigestion^?), 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. 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.  

^? with no known organic cause
* individual results may vary
^§ use under medical supervision

References

1. IQVIA ProVoice Surveys. IBgard Is the #1 Gastroenterologist Recommended Peppermint Oil for Patients with IBS (2015-2020) [Among gastroenterologists who recommended peppermint oil for IBS].
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. 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
4. 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.
5. Lacy B, Epstein M, Corsino P. 36 month surveillance data confirms safety profile of a novel peppermint oil formulation for IBS (PO-SST). In: Digestive Disease Week Annual Conference - EPoster.; 2020.
6. IQVIA ProVoice Survey. IBgard Is the #1 Gastroenterologist Recommended Peppermint Oil for Patients with Digestive Issues [Among Gastroenterologists Who Recommended Peppermint Oil for Digestive Issues].; 2020.
7. Ford AC, Moayyedi P, Chey WD, et al. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. The American Journal of Gastroenterology. Published online 2018:S1?S18. doi:10.1038/s41395-018-0084-x
8. 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):505-512. doi:10.1097/MCG.0b013e3182a88357
9. 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
10. 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
11. 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
12. Canavan C, West J, Card T. The epidemiology of irritable bowel syndrome. Clinical Epidemiology. 2014;6(1):71-80. doi:10.2147/CLEP.S40245
13. Camilleri M, Lasch K, Zhou W. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. The confluence of increased permeability, inflammation, and pain in irritable bowel syndrome. American journal of physiology Gastrointestinal and liver physiology. 2012;303:G775?G785. doi:10.1152/ajpgi.00155.2012
14. 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. Published online 2003. doi:10.1046/j.1365-2036.2003.01421.x
15. 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.
16. Internal IMH data on file.

Calms the Angry Gut^® is a registered trademark of IM HealthScience. Daily Gut-Health Gardtm is pending approval for a registered trademark of IM HealthScience. Copyright © 2020 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.

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. Keep out of reach of children. Store at room temperature. Individual results may vary. Do not use if blister is torn or ripped or if there is any other evidence of tampering.  Please read package insert and the website for more information.

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SOURCE IM HealthScience