Comparative Analysis Of Three Studies Confirms Rapid Action Of Irritable Bowel Syndrome (IBS) Novel Delivery System With Equivalent Amount Of L-menthol (At Same Level As Seen In IBgard®)

HONOLULU, Oct. 19, 2015 /PRNewswire/ --

• Novel delivery system, Site Specific Targeting (SST^®), demonstrates a pattern of rapid action in three studies for Irritable Bowel Syndrome (IBS) management
• In one study,  there was a significant reduction reported in intensity of most bothersome IBS symptoms after 2 hours and frequency and intensity at 24 hours
• In real world study, 75.6 percent of patients reported experiencing relief within 2 hours

Comparative analysis of three studies reveals a consistent pattern of rapid action with Site Specific Targeting (SST^®) technology, a novel delivery system that delivers peppermint oil and its primary component L-menthol to the small intestine, the primary site of the disturbance in Irritable Bowel Syndrome (IBS). This data was presented during the American College of Gastroenterology's (ACG) 80^th Annual Scientific Meeting. The studies demonstrate that delivery of L-menthol to the small intestine, using SST^® delivery technology, continues to have a significant impact on the management of IBS. SST^® is the novel delivery technology in IBgard^®, a currently marketed medical food for IBS. ACG is the pre-eminent professional organization that delivers evidence-based health care to gastroenterology patients through scientific investigation, education, prevention and treatment.    

Data was presented from IBSRRET™ (Irritable Bowel Syndrome Response Rate Evaluation Trial), a single arm, multi-centered U.S. study of moderate-to-severe IBS patients taking a new product in advanced development, IBgard LPB. This study protocol measured a new, efficacy endpoint, which was the reduction in symptoms after 2 hours. IBSRRET™ showed a decrease in intensity and frequency of symptoms as early as 2 hours after the first dose, compared to symptoms at baseline.

Data was presented from IBSACT™ (Irritable Bowel Syndrome Adherence & Compliance Trial), a real world, observational study, which showed that 60.8 percent of IBS patients taking the currently marketed medical food, IBgard^®, needed only 1 to 2 capsules per day to obtain individualized relief from IBS symptoms.  In addition, 75.6 percent of the patients reported relief within 2 hours.

The comparative analysis included results from IBSREST™ (Irritable Bowel Syndrome Reduction Evaluation and Safety Trial) study, which studied the currently marketed IBgard^®.  This study yielded data similar to those in IBSRRET™ and IBSACT™, including the reduction in symptoms at 24 hours. The IBSREST™ study did not measure reduction in symptoms at 2 hours.

"Results from these studies demonstrate that delivery of L-menthol to the small intestine, using the Site Specific Technology (SST^®) delivery technology, is an important advance in the management of IBS," said Brooks D. Cash, M.D., Professor of Medicine in the Gastroenterology Division at the University of South Alabama in Mobile. "Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during a flare-up."

About IBSRRET™
The IBSRRET™ study evaluated reduction of 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. 

• Patients in the study taking IBgard LPB experienced a reduction in the intensity of their symptoms at 2 hours, which was statistically significant compared to baseline (P= 0.015)
• Patients experienced a reduction in the frequency and intensity of symptoms at 24 hours which was statistically significant compared to baseline (P= 0.018)

Significant Decrease in Intensity of Symptoms After 2 Hours:

• 20% decrease in bloating or distension from baseline (P=0.029)
• 29% decrease in constipation from baseline (P=0.048)
• 28% decrease in diarrhea from baseline (P=0.036)
• 28% decrease in passage of gas or mucus from baseline (P=0.041)
• 28% decrease in urgency of bowel movement from baseline (P=0.013)

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

Significant Symptom Relief Within 2 Hours:
When asked how long it takes for relief from abdominal pain, discomfort and/or bloating after taking IBgard^®, patients in IBSACT™ reported:

• 33.7% reported relief in less than 1 hour
• 41.9% reported relief in 1 to 2 hours
• 14.4% reported relief in 3-8 hours

About IBSREST™
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.

More Validation for IBgard^® and SST^® Technology
Two additional posters demonstrating the efficacy of IBgard^® with SST^® technology were presented at the ACG conference. One study demonstrated significant relief of IBS symptoms after the first dose as well as high levels of patient satisfaction and a willingness of patients to continue use of IBgard^® and recommend it to others.

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, urgency 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