For The Third Year In A Row, Gastroenterologists Nationwide Endorse Nonprescription FDgard® For Functional Dyspepsia (Meal-Triggered Indigestion(i)) (ii)

BOCA RATON, Fla., Aug. 23, 2019 /PRNewswire/ -- IM HealthScience^®, innovators of medical foods and dietary supplements, today announced that a high-quality, nationwide survey, conducted among a representative and projectable sample of U.S. gastroenterologists, revealed FDgard^® as the #1-recommended product for Functional Dyspepsia (FD or meal-triggered indigestionⁱ).ⁱⁱ

The results of a ProVoice survey, fielded in June 2019 by IQVIA, showed that FDgard was, by far, the market leader, with 67 percent of gastroenterologists' recommendations. ⁱⁱ

FDgard is a clinically studied, nonprescription medical food that employs a novel approach in the dietary management of FD. There are no approved Rx drugs for this highly prevalent condition.

FD has been characterized as recurring, often meal-triggered indigestion, with no known organic cause. About one in six Americans has Functional Dyspepsia.^6–8 It remains an area of high unmet medical need. FD remains under-diagnosed and under-treated and presents a significant management challenge for providers and patients. In addition to being associated with disturbances in nutritional intake, digestion, and absorption, troublesome FD gastrointestinal symptoms in the upper belly can include, at various times, one or all of the following: abdominal pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating, and belching. Since there are no approved drugs for FD, off-label Rx drugs are used to treat the condition, and patient dissatisfaction remains high.⁹ 

"FDgard is a specifically formulated medical food whose components are known to possess anti-inflammatory,^10,11 analgesic¹² and gastroprotective^13,14 properties," said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor of IM HealthScience. He added, "Not only can FD patients make progress toward normalizing their nutrient intake and uptake, but they now also can deal with the anticipatory anxiety of FD symptoms by taking FDgard before their meals."

Underscoring the importance of FDgard as a medical advance, Clinical and Translational Gastroenterology (CTG), a peer-reviewed journal, has published the U.S. results of a landmark, double-blind, placebo-controlled study, FDREST™ (Functional Dyspepsia Reduction Evaluation and Safety Trial). This study showed statistically significant, rapid reduction of Functional Dyspepsia (FD or recurring, meal-triggered indigestion) symptoms within 24 hours and, additionally, relief of severe FD symptoms.¹ The study was entitled "A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial." It was published in Clinical and Translational Gastroenterology, an American College of Gastroenterology (ACG) journal dedicated to innovative clinical work in the field of gastroenterology and hepatology.  Dr. William D. Chey, a globally recognized gastroenterology-science leader, was the lead author of the study.

The FDREST study demonstrated that patients who took COLM-SST (FDgard) on a daily and proactive basis 30 to 60 minutes before meals, along with commonly used off-label FD medications, compared to patients who took placebo along with commonly used off-label FD medications, experienced a statistically significant, rapid reduction of FD symptoms within 24 hours across the FD study population. This study had a higher hurdle than previous studies on a similar combination of ingredients. First, concomitant medications for FD symptoms were allowed in order to assess FDgard in a real-world setting. Second, only a subgroup of patients in FDREST was categorized into a high-symptom burden subgroup, while they constituted the entire groups in previous studies. Among this subgroup of patients with the high-symptom burden, FDgard showed efficacy at 24 hours. In spite of the polypharmacy and use of rescue medications for FD after 48 hours of the first dose, FDgard helped further improve symptoms at four weeks, especially in those high-symptom burden patients. In all cases, FDgard was safe and well-tolerated.

FDREST provides further validation of FDgard as a PreMeal Companion^® for the daily and proactive management of FD. 

Nonprescription FDgard is available to patients in the digestive aisle in major retailers nationwide, including CVS/pharmacy, Rite Aid, Walgreens, select Walmart locations, and many grocery stores. It can also be purchased online at Amazon.

About 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.

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 third year, "FDgard^® is the #1 gastroenterologist-recommended herbal product for patients with Functional Dyspepsia."

About Functional Dyspepsia (FD)
In FD, which is recurring, often meal-triggered indigestion with no known organic cause, the normal dietary intake, digestion and absorption of nutrients are disrupted, accompanied by symptoms which, at varying times, may include some or all of the following: abdominal pain or discomfort, early fullness during a meal, heaviness, pressure, nausea, bloating, or belching.  The permeability at the gut wall may be affected by the incursion of immune activators, including eosinophils.⁶ When physicians diagnose FD, they often identify patients who have had some or all of these FD symptoms for at least three months and with symptom onset six months previously.

About FDgard® 
FDgard^® is a nonprescription medical food designed to address the unmet medical need for products to help manage Functional Dyspepsia (FD or recurring, often meal-triggered indigestion) and its accompanying symptoms.  FDgard capsules contain caraway oil and l-Menthol, the primary component in peppermint oil, for the dietary management of FD. These two main ingredients are specially formulated to be available in a solid state and are triple-coated.  With the patented Site-Specific Targeting (SST^®) technology pioneered by IM HealthScience, FDgard capsules are designed to release individually triple-coated, solid-state microspheres of caraway oil and l-Menthol quickly and reliably where they are needed most in FD — the duodenum or upper belly. The l-Menthol helps with smooth muscle relaxation and provides analgesic and anti-inflammatory activities.^10,15,16 Caraway oil helps mitigate the effect of gastric acid on the stomach wall, helps to normalize gallbladder function, and may help to normalize motility in the small intestine (primarily the duodenum) and the stomach.^17–19 In addition to caraway oil and l-Menthol, FDgard provides fiber and amino acids (from gelatin protein). These ingredients have additional positive effects on the gut wall and thus help toward normalizing digestion and absorption.            

Caraway oil and peppermint oil have a history of working in FD. In multiple clinical studies, the combination of caraway oil and peppermint oil has been shown to manage FD and its accompanying symptoms.^20,21 Cisapride, no longer an FDA-approved pro-motility drug after its removal from the market in 2000 due to cardiovascular side effects, was shown to have efficacy similar to a caraway oil/peppermint oil formulation.²²

In addition to the landmark randomized control trial called FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial), FDgard has been validated in a real-world patient-reported outcomes trial, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial).⁵

Complete and final results from FDACT™, a study of 600 patients who took FDgard^®, were peer-reviewed and then selected for an oral presentation session delivered by William D. Chey, M.D., FACG, Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, at the World Congress of Gastroenterology at ACG 2017 in Orlando, Fla. The data showed a consistently high level of patient satisfaction and rapid improvement of FD symptoms with the product. A majority of patients (95 percent) reported major or moderate improvement in their overall FD symptoms, while many patients (86.4 percent) indicated experiencing relief from symptoms within two hours after taking FDgard. The findings from FDACT substantiate those data reported from previous peer-reviewed poster presentations of a randomized clinical trial (FDREST).^2–4

Many physicians are now recommending taking FDgard before a meal, as it enables the supportive effect of FDgard^® to start as early as possible. By reducing anticipatory anxiety related to meal-triggered indigestion, FDgard, as a PreMeal Companion®, provides the Shield of Confidence®.  The usual adult dose of FDgard is two capsules, 30 to 60 minutes before meals, up to two times a day, not to exceed six capsules per day.  While FDgard does not require a prescription, it must be used under medical supervision, since it is a medical food.  

About IM HealthScience^®
IM HealthScience^® (IMH) is the innovator of the medical foods IBgard^® and FDgard^® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD or recurring indigestion), respectively.  IBS may often migrate to FD, and vice versa, or both conditions may overlap in the same patient.²³ IMH rounds out its line of digestive products with Fiber Choice^®, a well-known, natural chewable prebiotic fiber supplement that helps with regularity. IMH^®, along with its sister company, Physician's Seal^® (PS), also co-markets the innovative sleep product, REMfresh^®.  REMfresh is the first and only continuous release and absorption melatonin (CRA-melatonin™) supplement for sleep. It is a 99 percent ultrapure melatonin that mimics the way the body naturally releases and maintains melatonin over a 7-hour period.

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. Both IMH and PS are dedicated to developing products to address overall health and wellness in digestive health and sleep. The IM HealthScience and Physician's Seal advantage comes from developing products based on patented, targeted-delivery technologies, including IPP^® (Ion-Powered Pump^®) and SST^® (Site-Specific Targeting®) technologies. 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.

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This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care 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 functional dyspepsia. Use under medical supervision. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.fdgard.com. Individual results may vary.

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SOURCE IM HealthScience