SAN DIEGO, May 23, 2016 /PRNewswire/ -- IM HealthScience® (IMH) today announced the nationwide availability of FDgard™, a new medical food specially formulated for the dietary management of Functional Dyspepsia (FD), which has been characterized as persistent or recurring indigestion. Currently, there are no options for doctors and their patients to manage FD.
FDgard™ was launched this month during Digestive Disease Week (DDW), the premier gastroenterology meeting of the American Gastroenterological Association, attended by over 13,000 gastroenterologists in the U.S. and around the world. FDgard™ is non-prescription and available in the digestive aisle at most CVS/pharmacy and Walgreens stores nationwide. While medical foods do not require U.S. Food and Drug Administration (FDA) pre-approval before marketing, they must comply with regulations. Medical foods must be used under medical supervision.
Functional dyspepsia (FD), a relatively common and often frustrating medical condition, occurs when the digestion and absorption of food nutrients may be disrupted. It is characterized by symptoms of upper abdominal pain or discomfort, early fullness with a meal, nausea, belching and bloating with no known organic cause. FD is a disorder of sensation and movement in the organs of the upper digestive tract, where the normal downward pumping and squeezing is altered. One in six adults in the U.S. suffer from FD and the cause of the condition is unknown.1
FDgard™ is designed to address an unmet medical need for products to help in managing FD and its accompanying symptoms. FDgard™ contains a combination of caraway oil and peppermint oil (in the form of its principal component, l-Menthol). The caraway oil/peppermint oil combination has been shown in several clinical studies to be effective in managing FD.
New Option For Persistent and Recurrent Indigestion
"The Gastroenterologists who have heard of FDgard™ welcome its arrival and look forward to helping their FD patients with this new option," said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience® LLC, innovators of FDgard™. "A strong body of science supports this combination product."
Clinical Studies Support Caraway Oil and Peppermint Oil Combination
Six randomized, placebo-controlled studies of over 700 FD patients demonstrated that the combination of caraway oil and peppermint oil (primary component l-Menthol) is effective in managing the syndrome of FD symptoms, which include the intensity of upper belly pain, pain frequency, and discomfort from indigestion, intensity of sensations of pressure, abdominal heaviness and fullness.
Analysis of a 4-week, randomized, placebo-controlled multicenter trial in Europe of 96 FD patients taking a fixed combination of 90 mg peppermint oil (41.5 mg l-Menthol) and 50 mg caraway oil twice a day resulted in:
Reduction in Sensation of Pressure, Heaviness or Fullness at 4 weeks
- 43.5% reduction in sensation of pressure, heaviness or fullness in the active arm from baseline at 4 weeks
- 22.3% reduction in sensation of pressure, heaviness or fullness in the placebo arm from baseline at 4 weeks (P=0.0005)
Reduction in Pain Intensity Form Baseline at 4 weeks
- 40% reduction in pain intensity in the active arm compared to baseline at 4 weeks
- 22% reduction in pain intensity in the placebo arm compared to baseline (P=0.0003)
Favorable Global Improvement Scores at 4 weeks
- Over 90% in the active arm reported an improvement from start of study
- 67% in the active arm reported very much/much improved scores from start of study (P=0.00005)2
About Functional Dyspepsia (FD)
Approximately 30 percent of adults suffer from dyspepsia, and about half are estimated to have FD, or non-ulcer dyspepsia.3 In FD, the normal digestive processes may be disrupted as well as 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 customarily identify patients as follows: patients should have these symptoms for at least three months with symptom onset six months previously.
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 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 neutralize the effect of gastric acid on the stomach wall and helps to normalize gallbladder function as well as delivers promotility and analgesic action in the small intestine (the duodenum) and stomach.
FDgard™ uses new, targeted delivery science to calm the angry upper belly™ through the precision of SST® technology. In addition to caraway oil and l-Menthol, FDgard™ also provides fiber and protein.
Caraway oil and peppermint oil have a history of working in FD. Until now, targeted delivery to the upper belly has posed a challenge. 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.
The usual adult dose of FDgard™ is 2 capsules, as needed, 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.
FDgard™ is available in the digestive aisle of most CVS/pharmacy and Walgreens stores nationwide.
About IM HealthScience®
IM HealthScience® (IMH) 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. 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.FDgard.com to learn more about FDgard®.
About Digestive Disease Week
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW take place May 21-24, 2016, at the San Diego Convention Center, San Diego, CA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
1 Copyright © 1997 International Foundation for Functional Gastrointestinal Disorders (IFFGD). All rights reserved. Functional Dyspepsia and IBS: Incidence and Characteristics.
2 May, B., Kohler, S., & Schneider, B. (2000, December). Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Alimentary Pharmacology & Therapeutics, 14(12): 1671-1677. doi: 10.1046/j.1365-2036.2000.00873.x
3 Copyright © 1997 International Foundation for Functional Gastrointestinal Disorders (IFFGD). All rights reserved. Functional Dyspepsia and IBS: Incidence and Characteristics.
4 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.
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SOURCE IM HealthScience