U.S. Gastroenterologists Endorse Non-Prescription FDgard® For Functional Dyspepsia (Recurring Indigestion)

Wednesday, November 1, 2017 General News
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- Previously presented clinical study demonstrated unprecedented symptom reduction and rapid relief of FD symptoms in only 24 hours with FDgard®

BOCA RATON, Fla., Nov. 1, 2017 /PRNewswire/ -- IM HealthScience®, innovators

of FDgard®, a clinically studied, non-prescription medical food using a novel approach in the dietary management of Functional Dyspepsia (FD), revealed results of a nationwide survey conducted among 203 U.S. gastroenterologists, who endorsed FDgard® as the #1 recommended herbal product for FD (or recurring indigestion).

The survey revealed that FDgard® was by far the market leader with close to 55 percent of physician recommendations. The next brand on the list was a distant second with about 18 percent of physician recommendations.

FD has been characterized as recurring indigestion with no known organic cause and is an area of high unmet medical need. FD remains poorly recognized and presents a significant management challenge for providers and patients. Gastrointestinal symptoms can include epigastric pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating and belching.  Currently, there are no approved drugs for FD. Off-label medications are used to treat the condition and patient dissatisfaction remains high.1  

"Functional dyspepsia can have a significant impact on a patient's quality of life," said Michael Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor, of IM HealthScience, LLC®. "In fact, we believe that FDgard® possesses anti-inflammatory, analgesic, and gastro-protective properties, which likely are responsible for the rapid relief and steady improvement of FD symptoms in patients. This is why many physicians are starting to recommend taking FDgard® daily and before a meal, so patients can more proactively manage their FD symptoms."   

At the recent World Congress of Gastroenterology at ACG 2017 in Orlando, Fla., complete and final results from a real-world, observational study of 600 patients who took FDgard®, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), were selected after peer review and presented by William D. Chey, M.D., F.A.C.G., Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor. The data showed that there was a consistently high level of patient satisfaction and rapid improvement of FD symptoms with the product. The findings from FDACT substantiate those data reported from a previous peer-reviewed poster presentation.

The landmark, multi-centered, post-marketing, parallel group, U.S.-based study, FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial), which showed that patients with FD who received FDgard® versus placebo plus commonly used, off-label FD medications, experienced a statistically significant reduction in Postprandial Distress Syndrome (PDS) symptoms (early satiety, abdominal heaviness, pressure and fullness) and near statistical significance in Epigastric Pain Syndrome (EPS) symptoms (epigastric pain or discomfort and burning) at 24 hours.

About QuintilesIMS QuintilesIMS is a leading integrated information and technology-enabled healthcare service provider worldwide, dedicated to helping its clients improve their clinical, scientific and commercial results. Formed through the merger of Quintiles Transnational Holdings Inc. and IMS Health Holdings, Inc., QuintilesIMS's approximately 50,000 employees conduct operations in more than 100 countries. Companies seeking to improve real-world patient outcomes through treatment innovations, care provision and access can leverage QuintilesIMS's broad range of healthcare information, technology and service solutions to drive new insights and approaches. QuintilesIMS provides solutions that span clinical to commercial, bringing customers a unique opportunity to realize the full potential of innovations and advanced healthcare outcomes.

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. Manufacturers use ProVoice for claim substantiation, promotion measurement and HCP targeting.

QuintilesIMS fielded a U.S. survey among 203 U.S. gastroenterologists between April 26, 2017, through May 6, 2017, for IM HealthScience®. The ProVoice survey methodology validated the claim at a 99 percent confidence level that for the first year, "FDgard® is the #1 gastroenterologist-recommended herbal product for patients with FD."

About Functional Dyspepsia (FD) About one in six Americans have Functional Dyspepsia.2 This condition can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.3

In FD, which is recurring indigestion with no known organic cause, the normal digestive processes are disrupted along with the digestion and absorption of food nutrients. FD is accompanied by symptoms, such as epigastric pain or discomfort, epigastric burning, postprandial fullness, early satiation, bloating in the upper abdomen, nausea and belching. When doctors diagnose FD, they often identify patients as follows: patients should have these symptoms for at least three months with symptom onset six months previously.

About FDgard®  FDgard® is a non-prescription medical food designed to address an unmet medical need for products to help in managing FD and its accompanying symptoms.  FDgard® capsules contain caraway oil and l-Menthol, the primary component in peppermint oil, for the dietary management of Functional Dyspepsia (FD). With its patented Site Specific Targeting (SST®) technology, pioneered by IM HealthScience®, FDgard® capsules release individually triple-coated, solid-state microspheres of caraway oil and l-Menthol quickly and reliably where they are needed most in FD -- the upper belly. The l-Menthol helps with smooth muscle relaxation and caraway oil helps mitigate the effect of gastric acid on the stomach wall and also helps to normalize gallbladder function as well as deliver promotility and analgesic action in the small intestine (the duodenum) and the stomach.4,5,6 In addition to caraway oil and l-Menthol, FDgard® also 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, such as reducing the intensity of epigastric pain, pain frequency, dyspeptic discomfort and reducing the intensity of sensations of pressure, abdominal heaviness and fullness…significantly better than placebo.

FDgard® was studied in a landmark, multi-centered, post-marketing, parallel group, U.S.-based study, called FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial). The study showed that patients with FD, who received FDgard® versus placebo plus commonly used, off-label FD medications, experienced a statistically significant reduction in Postprandial Distress Syndrome (PDS) symptoms (early satiety, abdominal heaviness, pressure and fullness) and near statistical significance in Epigastric Pain Syndrome (EPS) symptoms (epigastric pain or discomfort and burning) at 24 hours. In spite of the polypharmacy and use of rescue medications for FD after 48 hours of first dose, FDgard® helped further improve symptoms at 4 weeks.

Additionally, results from a real-word observational study of 600 patients who took FDgard®, called FDACT (Functional Dyspepsia Adherence and Compliance Trial), showed that there was 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 symptoms of FD, while many patients (86.4 percent) indicated experiencing relief from symptoms within 2 hours after taking FDgard®. The findings from FDACT™ substantiate those data reported from a previous peer-reviewed poster presentation.

Currently, there are no approved drugs for FD, and off-label medications are used to treat the condition.

The usual adult dose of FDgard® is 2 capsules, as needed, up to two times a day, not to exceed six capsules per day. Many physicians are now recommending taking FDgard® before a meal, as it enables the supportive effect of FDgard® to start as early as possible. While FDgard® does not require a prescription, it must be used under medical supervision, since it is a medical food. FDgard® is available to patients in the digestive aisle at most Rite Aid, CVS/pharmacy and Walgreens stores nationwide.

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 modified-release 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.

1 Lacy, B.E., Weiser, K.T., Kennedy, A.T., Crowell, M.D., & Talley, N.J. (2013). Functional dyspepsia: the economic impact to patients. Alimentary Pharmacology & Therapeutics, 38:170-177. doi: 10.111/apt.12355.2 Talley, N.J. (2017, May). Functional Dyspepsia: Advances in Diagnosis and Therapy. Gut and Liver, 11(3), 349-357. doi:  10.5009/gnl16055.3 Lacy, B.E., Weiser, K.T., Kennedy, A.T., Crowell, M.D., & Talley, N.J. (2013). Functional dyspepsia: the economic impact to patients. Alimentary Pharmacology & Therapeutics, 38:170-177. doi: 10.111/apt.12355.4 Shams, R., Oldfield, E.C., Copare, J., & Johnson, D.A. (2015). Peppermint Oil: Clinical Uses in the Treatment of Gastrointestinal Diseases. JSM Gastroenterology and Hepatology, 3 (1): 1035-1046. 5 Sun, J. (2007). D-Limonene: Safety & Clinical Applications. Alternative Medicine Review, 12 (3): 259-264.6 Goncalves, J.C.R., Alves, A. de Miranda H., de Araujo, A.E.V., Cruz, J.S., & Araujo, D.A.M. (2010). Distinct effects of carvone analogues on the isolated nerve of rats. European Journal of Pharmacology, 645:108-112. doi: 10.1016/j.ejphar.2010.07.027.

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SOURCE IM HealthScience



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