Real-World Data From Surveillance Study Confirms Excellent Safety And Tolerability Profile Of IBgard® At 24 Months
- Irritable Bowel Syndrome Safety Update at 24 months (IBSSU-24) reconfirms excellent safety profile seen in IBSSU-12
- No serious adverse events for IBgard reported; an estimated 773,322 individual patients used the product since the beginning of the reporting period
- IBgard is a clinically studied, nonprescription medical food for the dietary management of Irritable Bowel Syndrome (IBS)
Apr 19, 2018, 01:18 ET
BOCA RATON, Fla., April 19, 2018 /PRNewswire/ -- IM HealthScience® (IMH) today announced favorable results from its Irritable Bowel Syndrome Safety Update at 24 Months (IBSSU-24), a real-world surveillance study reporting on the safety and tolerability profile of IBgard®. It is estimated that 773,322 individual patients used the product since the beginning of the surveillance. No serious adverse events were reported. Additionally, the self-reporting rates and patterns of non-serious adverse events were low with only 626 events received. The top-reported, non-serious adverse events were abdominal pain/discomfort, and diarrhea. Both symptoms are very commonly reported in patients with Irritable Bowel Syndrome (IBS).
The IBSSU-24 captured and analyzed serious and non-serious adverse event reports for IBgard over a 24-month period from October 5, 2015 to September 30, 2017.
"It is not common for a pharmaceutical-level, post-marketing safety monitoring study to be conducted for a medical food," said Michael S. Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. "The findings from IBSSU-24 reaffirm the safety and tolerability profile of IBgard in real-world settings. This calculation results in an estimated 0.07 percent adverse event reporting rate for IBgard. The outcome does not cause any concern for the safety profile of the product. In fact, it may be difficult to separate the scatter of the events from background noise associated with the IBS population."
Dr. Epstein added, "Heartburn and burning are common side effects reported with older peppermint oil products. However, in IBSSU-24, there was only 1 report of anal burning and 7 reports of gastroesophageal reflux disease (GERD), which is remarkably low."
About IBSSU-24
The Irritable Bowel Syndrome Safety Update at 24 Months (IBSSU-24) is a real-world surveillance study reporting on the safety and tolerability profile of IBgard among an estimated 773,322 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, 2017. 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. Only 626 non-serious adverse events were received, many of which were consistent with commonly reported symptoms of IBS. The top-reported, non-serious adverse events were abdominal pain/discomfort/distension (65), diarrhea (59), dyspepsia (56), constipation (29), flatulence (27), and throat irritation (27).
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 its actions help manage IBS. The food nutrients in IBgard (peppermint oil along with fiber and amino acids) may help reduce the low-grade, reversible inflammation found in some IBS patients and help normalize gut mucosal barrier function. Additionally, peppermint oil has also been shown to help normalize intestinal transit time.
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-M and IBS-D were included in the study. The study findings were accepted and published in the February 2016 issue of Digestive Diseases and Sciences, a leading, peer-reviewed scientific journal. 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.
Additionally, results from a real-word observational study of 630 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, 70 percent of the patients felt relief of abdominal pain, discomfort and/or bloating within 2 hours while 94 percent of patients reported relief within 24 hours after taking IBgard.
Currently, there are limited options for patients with IBS that offer effective and rapid relief, especially during flare-ups.
Over 10,000 healthcare practitioners, including 3,000 gastroenterologists, are estimated to have already used IBgard for their patients. For the third consecutive year, IBgard continues to be the #1 recommended peppermint oil for IBS among gastroenterologists nationwide by an overwhelming margin.
Like all medical foods, IBgard does not require a prescription, but it must be used under medical supervision. Only a physician can diagnose IBS. 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. Many physicians are now recommending taking IBgard 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 independent drug stores and grocery stores across the country.
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.
SOURCE IM HealthScience