In the Longest-Ever String of Yearly Surveys on Gastroenterologists' Preferences for Recommending Products for IBS, IBgard Continues to Widen its Already Pre-Eminent "#1 Recommended"(1) Status

Nonprescription IBgard continues to benefit from convincing efficacy,(2-4) safety,(2-5) tolerability, and affordability data-In a well-recognized national survey, IBgard® again achieves the #1 share of gastroenterologist recommended(1) for the fifth year in a row-IBgard's pre-eminent "#1 recommended" status widens to an 80% share of recommendations(1)-Three separate, previously peer-reviewed studies,(2,3,5) published or presented at major medical conferences confirm the efficacy, safety and tolerability profile of IBgard-Real-world, patient-reported outcome studies show high level of patient satisfaction and rapid improvement of IBS symptoms with IBgard(3)-A 36-month post-marketing surveillance study(6) confirms IBgard's excellent real-world safety and tolerability

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IM HealthScience

Aug 07, 2019, 23:40 ET

BOCA RATON, Fla., Aug. 7, 2019 /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. IBgard is the #1-recommended peppermint oil product for the fifth consecutive year1 and is by far the leader in its own market with 80 percent of physician recommendations.1 IBgard benefits from a unique, patented, triple-coated, solid-state microsphere-based technology. This technology enables microspheres carrying peppermint oil to rapidly transit 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 3 to 4 hours to help coat the entire small intestine2,3.

This type of more distal delivery was recommended in the American College of Gastroenterology Monograph on IBS in.7 In this 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 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,2–5 is why IBgard has become such a popular mainstay in the management of IBS, a difficult-to-treat condition." 

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already recommended IBgard for their patients. Over 2 million patients are estimated to have taken IBgard since its launch in 2014.

About Irritable Bowel Syndrome
One in six Americans experience 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 needs proactive management over a long period since up to 70% of patients experience persistent 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 inflammation as a potential contributor to abdominal pain and altered stool form.

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 Ultramen®, an ultra-purified 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 has important benefits in IBS management. The food nutrients in IBgard -- peppermint oil along with fiber and amino acids -- are designed to help reduce the low-grade, often temporary, reversible inflammation found in some IBS patients and to help normalize gut mucosal barrier function. Additionally, peppermint oil has been shown to help normalize intestinal transit time.13

IBgard has been on the US market since 2014. Like all medical foods, IBgard does not require a prescription but 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, Rite Aid, Kroger's, Publix and soon in Dollar General stores across the country.

Growing Body of Convergent and Concurring Evidence on the Safety and Efficacy of IBgard®
In yet another important study on IBgard, IBSSU36, IBS Safety Update at 36 months, IBgard again indicated no pattern of heartburn.6  This important and unprecedentedly long safety update for a nonprescription IBS product is part of the growing convergent scientific database that supports the pre-eminent standing of IBgard in nonprescription IBS products. In the patient-reported outcomes study IBSACT, 75% of patients reported a beneficial response within 2 hours of taking IBgard.3

IBSREST was a randomized, double-blind, placebo-controlled, multicenter trial which demonstrated that IBgard provided a reduction in eight hallmark symptoms of IBS:  abdominal pain or discomfort, bloating or distention, diarrhea, constipation, feeling of incomplete evacuation, urgency, pain at evacuation, and gas or mucus.2 A statistically significant reduction of symptoms was seen at 24 hours, and the benefit expanded at four weeks.2 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

2018 ACG IBS Monograph Supports Use of Peppermint Oil That Provides More Distal Delivery in the Gastrointestinal Tract
Consistent with the previous 2014 ACG IBS Monograph, the newly updated June 2018 Monograph continued to include peppermint oil as a credible and viable option for IBS.7 For the first time, the Monograph took into account findings from the landmark clinical trial for IBgard, called IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial).  In fact, IBSREST was referenced five times in the 2018 Monograph and was listed among the two studies "with a low risk of bias."7 Importantly, this latest version of the Monograph provides specific support for the type of formulation used in IBgard.

Peppermint oil's safety and efficacy profile includes data published in 2014 in the Journal of Clinical Gastroenterology in a study entitled "Peppermint oil for the treatment of irritable bowel syndrome: a systematic review and meta-analysis" (Khanna et al, 2014)8 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." In this study, heartburn, however, emerged as a side effect in the older formulations that were studied.  An additional meta-analysis study, mentioned in the 2018 ACG IBS Monograph, noted the challenge of heartburn in IBS patients10 was four times that of the non-IBS population. The Khanna study was one of the important studies8–10 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 with  more distal delivery were needed to avoid the uncomfortable side effect of heartburn.

IBgard, with its reliable release of solid-state, triple-coated, sustained-release microspheres of peppermint oil, enables more distal delivery.

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 June 2019 among 202 U.S. gastroenterologists for IM HealthScience. The ProVoice survey methodology validated the claim at a 99 percent confidence level that for the fifth consecutive year, "IBgard® is the #1 gastroenterologist-recommended peppermint oil for patients with IBS."

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.

 References

  1. IQVIA ProVoice Survey. IBgard Is the #1 Gastroenterologist Recommended Peppermint Oil For Patients with IBS.; 2019.[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. 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. Cash BD, Epstein MS, Shah S. Peppermint Oil with Site Specific Targeting is an Effective Therapy for Irritable Bowel Syndrome with Mixed Bowel Habits. Intern Med Rev. 2017;3(9):1-20.
  5. 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.
  6. IM HealthScience. 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. IBgard.com. Press Release 2019.
  7. 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
  8. 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
  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. J Ethnopharmacol. 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. Am J Gastroenterol. 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. Aliment Pharmacol Ther. 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. Clin Epidemiol. 2014;6(1):71-80. doi:10.2147/CLEP.S40245
  13. 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. Aliment Pharmacol Ther. 2003. doi:10.1046/j.1365-2036.2003.01421.x

*Primarily based on IBSREST2
**Primarily based on IBSACT3

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.

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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