HEALTHCARE PROFESSIONALS

Unprecedented 3-Year Safety Data Unveiled at Digestive Disease Week (DDW) Indicates No Pattern of Heartburn with IBgard®, an Advanced Technology Peppermint Oil, Contrary to Heartburn Issues with Older Technologies

Data from a 36-month, real-world, post-marketing study confirms 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 Monograph
    1, 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. – (May 5, 2020) – 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/epsWelcome.cfm?CFID=7230579&CFTOKEN=7d1a929b89a19c8a-5A2C8DBA-C404-83A0-BF151D97C9E5D145

The peer-reviewed and published e-poster
is titled, “36 MONTH SURVEILLIANCE 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
post-marketing 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 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.

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 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,
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.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 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.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 IBSamong 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.comwww.FDgard.comwww.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):505-512. 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. 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.
  9. 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.
  10. 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.
  11. 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.

§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. 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.

Leave a Comment





Access to this section is intended for Healthcare Practitioners only.

Please confirm below that you are a Healthcare Practitioner or click here to return to the consumer section of the site.

Confirm