Results Of Clinical Data Presented At The Annual Meeting Of The American College of Gastroenterology Demonstrate Significant Relief Of Irritable Bowel Syndrome (IBS) Symptoms And High Levels Of Patient Satisfaction With IBgard®, A Medical Food Using A New Approach In Managing IBS

HONOLULU, Oct. 19, 2015 /PRNewswire/ -- New clinical data on IBgard^®, a medical food using a novel approach in managing irritable bowel syndrome (IBS), demonstrated significant relief of IBS symptoms after the first dose as well as high levels of patient satisfaction with the product, according to presentations during the American College of Gastroenterology's (ACG) 80^th Annual Scientific Meeting.  ACG is the pre-eminent professional organization that delivers evidence-based health care to gastroenterology patients through scientific investigation, education, prevention and treatment.

Data from a post-study assessment of moderate to severe IBS patients in the landmark IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial) study and the real world, observational IBSACT™ (Irritable Bowel Syndrome Adherence & Compliance Trial) study revealed a consistently high level of patient satisfaction with the overall improvement of their IBS symptoms. In IBSREST™, the overall patient satisfaction rate was over 80 percent.  Additionally, patients in the real world study, which measured patient adherence and compliance, reported an overall satisfaction rate of greater than 85 percent after taking IBgard^® with 61 percent of patients needing only 1 to 2 IBgard^® capsules per day to achieve relief from IBS symptoms.

IBS is a frustrating, underdiagnosed, and undertreated condition characterized by abdominal pain and abnormal bowel habits that affects an estimated 15-20 percent of the U.S. population. Patients with IBS are often not satisfied with the treatments they receive for this chronic disorder.

IBgard^® is a medical food specially formulated for the dietary management of IBS and is the first product using a patented, breakthrough technology called Site Specific Targeting (SST^®), which delivers sustained released microspheres of an ultra-purified peppermint oil, quickly and reliably to the small intestine where its actions helps manage IBS. 

"Historically IBS patients have reported low satisfaction with available treatment options, especially patients suffering with moderate to severe IBS," said Michael S. Epstein, M.D., Chief Medical Advisor, IM HealthScience^® LLC. "Looking at the combined analysis of the clinical trial with information on real world use among IBS patients, the value of this effective, new delivery system for peppermint oil to help provide relief for this chronic condition is well demonstrated."

Results Show Significant Improvement and Patient Satisfaction
In patients taking IBgard^®, overall improvement was accessed at four endpoints, with results showing:

• Overall improvement in IBS symptoms:
  • 88.3% in IBSREST™ and 98.1% in IBSACT™
• Overall improvement in quality of life:
  • 88.3% in IBSREST™ and 92.7% in IBSACT™
• Overall improvement in abdominal pain and cramping:
  • 85.3% in IBSREST™ and 95.8% in IBSACT™
• Overall improvement in bowel regularity:
  • 82.3% in IBSREST™ and 84.6% in IBSACT™

Additionally, patients taking IBgard^® were asked how likely they were to recommend IBgard^® and to continue taking IBgard^®.

• Likely to recommend IBgard^® to family and friends who also suffer from IBS:
  • 94.1% in IBSREST™ and 97% in IBSACT™
• Likely to continue taking IBgard^® for their IBS:
  • 88.3% in IBSREST™ and 99.3% in IBSACT™

About the Research
The IBSREST™ study was a 4-week, randomized, placebo-controlled, double-blind clinical trial of patients reporting average daily IBS-related abdominal pain of at least 4 on a 10-point scale. An end-of-study questionnaire, which was part of the protocol design, was used to evaluate the overall satisfaction with the relief of IBS symptoms for 35 subjects in the active arm.

The results of IBSREST™ were first presented during the Digestive Disease Week, the world's premier gastroenterology meeting of the American Gastroenterological Association in May 2015.

IBSACT™ surveyed over 250 IBS patients who were using IBgard^® in the general population to assess satisfaction and dosing frequency. The general patient population was allowed flexible dosing.

More Validation for IBgard^® and SST^® Technology
Two additional posters demonstrating the efficacy of IBgard^® and a developmental formulation containing the same level of L-menthol as IBgard^® were presented at the ACG conference. L-menthol is the principal component of IBgard.  One study demonstrated that 41.5 mg of L-menthol, delivered to the small intestine through SST^® (the same technology used in IBgard^®), provided rapid relief of IBS symptoms within two hours.

Another poster reported on IBgard^® to successfully manage viscerosensory symptoms in patients with IBS-M (mixed diarrhea and constipation) and IBS-D (diarrhea predominant). The results demonstrated that IBgard^® provided significant relief in multiple viscerosensory symptoms of IBS, such as abdominal pain, bloating, and sensation of incomplete rectal evacuation.

About Irritable Bowel Syndrome
One in six Americans experience Irritable Bowel Syndrome (IBS), a frustrating, underdiagnosed and undertreated condition characterized by abdominal pain associated with alteration in stool frequency and/or form. Bloating is also a common symptom experienced by patients with IBS.  Doctors are not sure what causes IBS and it is likely that there are numerous etiologies that manifest as a similar syndrome of symptoms. There is currently no cure for IBS and management options are limited.

About IBgard^®  
IBgard^® is a medical food containing L-menthol, the principal component in peppermint oil, which has been shown to have significant impact on the management of IBS symptoms. In multiple clinical studies, peppermint oil has been shown to provide relief from IBS symptoms. Peppermint oil can help normalize the digestion of food and absorption of nutrients, which have been compromised by IBS. Peppermint oil has also been shown to normalize intestinal transit time. With its patented SST^® technology, pioneered by IM HealthScience^®, IBgard^® capsules release Ultramen^®, an ultra-purified peppermint oil, in the small intestine.

Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard^® for their patients. While IBgard^® does not require a prescription, as a medical food, it must be used under medical supervision. The usual adult dose of IBgard^® is 1-2 capsules as needed, up to three times a day, not to exceed 8 capsules per day.

IBgard^® is now accessible to consumers in the digestive aisle at most CVS/pharmacy and Walgreens stores nationwide. For more information, visit www.IBgard.com to learn more about IBgard^®.

About IM HealthScience^®
IM HealthScience^® is a privately held company based in Boca Raton, Florida, that developed IBgard^®. 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 gastrointestinal issues where there is a high, unmet need, including Irritable Bowel Syndrome (IBS), Functional Dyspepsia, Ulcerative Colitis, and Crohn's Disease. The

IM HealthScience^® advantage comes from developing products based on its patented, targeted-delivery technologies called Site Specific Targeting (SST^®).

SOURCE IM HealthScience