For The Second Year In A Row, Gastroenterologists Nationwide Endorse Non-Prescription FDgard® For Functional Dyspepsia (Meal-Triggered Indigestion) [i]
Published: Jul 03, 2018
- In a national survey, FDgard® achieved the #1 share of gastroenterologist recommendations for Functional Dyspepsia (FD) [ii] or meal-triggered indigestion for the second year in a row
- Previously presented clinical study demonstrated unprecedented symptom reduction and rapid relief of FD symptoms in only 24 hours with FDgard [iii]
- Real-world observational study showed high level of patient satisfaction and rapid improvement of FD symptoms with FDgard
- Functional Dyspepsia, known for its symptoms of meal-triggered indigestion, impacts an estimated 1 in 6 adults in the U.S. and remains an area of high unmet medical need
BOCA RATON, Fla., July 3, 2018 /PRNewswire/ -- IM HealthScience®, innovators of medical foods and dietary supplements, today announced a high-quality, nationwide survey conducted among a representative and projectible sample of U.S. gastroenterologists, which revealed FDgard® as the #1-recommended product for Functional Dyspepsia (FD) or meal-triggered indigestion.iv FDgard is a clinically studied, non-prescription medical food using a novel approach in the dietary management of FD.
The results of a ProVoice survey, fielded in June 2018 by IQVIA, showed that FDgard was by far the market leader with close to 58.3 percent of physician recommendations. The next brand on the list was a distant second with about 16.3 percent of physician recommendations.
FD has been characterized as meal-triggered indigestion with no known organic cause. About one in six Americans have Functional Dyspepsia.1 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. 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.2
"Functional dyspepsia can have a significant impact on a patient's quality of life," said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor, of IM HealthScience, LLC. "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. FDgard is a great addition for fast relief of frustrating functional dyspepsia symptoms. The combination of l-Menthol and caraway oil works synergistically to address both the pain, pressure and early fullness that people with meal-triggered indigestion or functional dyspepsia experience. Patients also appreciate that its natural ingredients produce minimal side effects. I appreciate having this effective, non-prescription option for my patients, so more patients can proactively manage their condition by taking FDgard before their meals."
FDgard is available to patients in the digestive aisle in major retailers nationwide, such as CVS/pharmacy, Rite Aid, Walgreens, select Walmart, 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. Manufacturers use ProVoice for claim substantiation, promotion measurement and HCP targeting.
IQVIA fielded a survey in June 2018 among 202 U.S. gastroenterologists for IM HealthScience. The ProVoice survey methodology validated the claim at a 99 percent confidence level that for the second year, "FDgard® is the #1 gastroenterologist-recommended herbal product for patients with Functional Dyspepsia."
In FD, which is meal-triggered indigestion with no known organic cause, the normal digestive processes are disrupted along with epigastric burning and digestion and absorption of food nutrients. FD is accompanied by symptoms, such as discomfort, epigastric burning, postprandial fullness, early satiation, bloating in the upper abdomen, epigastric pain, 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.
FDgard® is a non-prescription medical food designed to address an unmet medical need for products to help in managing FD or 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 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 took FDgard on a daily and proactive basis, 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.v
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, at the World Congress of Gastroenterology at ACG 2017 in Orlando, Fla. The data 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 of a randomized clinical trial (FDREST).vi
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.
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.
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.
1 Talley, N.J. (2017, May). Functional Dyspepsia: Advances in Diagnosis and Therapy. Gut and Liver, 11(3), 349-357. doi: 10.5009/gnl16055.
2 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.
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.
i Among all herbal products for functional dyspepsia.
ii With no known organic cause.
iii FDREST (Functional Dyspepsia Reduction and Evaluation Safety Trial). Peer reviewed and selected for oral presentation at the American Gastroenterology Annual Meeting, October 2017.
iv With no known organic cause.
v FDREST (Functional Dyspepsia Reduction and Evaluation Safety Trial). Peer reviewed and selected for oral presentation at the American Gastroenterology Annual Meeting, October 2017.
vi FDREST. Peer reviewed and approved poster presentation, Digestive Diseases Week (DDW), Chicago, May 2017.
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SOURCE IM HealthScience