Gail S. Thornton
West Mill Consulting
IN A PEER-REVIEWED ARTICLE IN A LEADING GASTROENTEROLOGY JOURNAL, NONPRESCRIPTION FDgard® IS ADDED TO TREATMENT ALGORITHM FOR THE MANAGEMENT OF FUNCTIONAL DYSPEPSIA (FD)
• Functional Dyspepsia (FD), known for its symptoms of meal-triggered indigestion, impacts up to 10% to 24% of the population1
• FDgard®, a patented, solid-state microsphere formulation of caraway oil and l-Menthol, represents an important medical advance; there are no approved Rx drugs for FD
• Previously peer-reviewed and published clinical study demonstrated unprecedented rapid relief of FD symptoms in only 24 hours with FDgard2
BOCA RATON, Fla. – (March 9, 2020) – IM HealthScience® (IMH), innovators of nonprescription gastrointestinal products, announced today that the February 2020 issue of Gastroenterology and Hepatology, a widely read, peer-reviewed journal, published an article entitled, “Functional Dyspepsia: A Review of the Symptoms, Evaluation and Treatment Options.”1 In that review paper, the authors included FDgard® as part of their treatment algorithm in the management of Functional Dyspepsia.
“It is gratifying to note that FDgard was the only product included by name in this treatment algorithm for FD,” said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. “As the authors conclude, functional dyspepsia is a clinically challenging diagnosis…and there are lackluster treatment options. FDgard was specifically developed for the daily management of FD. It possesses anti-inflammatory, analgesic, and gastro-protective properties, which likely are responsible for the rapid relief seen among patients taking FDgard. It is very appropriate for this product to be discussed in the paper and included in this treatment algorithm.”
Increasing Evidence of the Safety and Efficacy of FDgard®
In addition to this algorithm, FDgard® is supported by an important randomized controlled trial (FDREST™)2, a patient-reported outcomes study (FDACT)3, and a two-year post-marketing surveillance study (FDSU24).4
FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial) was a multi-centered, post-marketing, parallel-group, U.S.-based study conducted at seven university-based or gastroenterology research-based centers (study period July 1, 2015 to September 1, 2016). The study was designed to compare the efficacy, safety, and tolerability of FDgard plus commonly used, off-label medications for FD vs. a control group of placebo plus commonly used, off-label medications prescribed for FD. ††
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. Despite 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.
Underscoring the importance of FDgard as a medical advance, Clinical and Translational Gastroenterology (CTG), a peer-reviewed journal, has published the results of FDREST. The article was titled “A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial.” Dr. William D. Chey, M.D., FACG, Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, and a globally recognized gastroenterology-science leader, was the lead author of the article.
About Functional Dyspepsia (FD)
Functional Dyspepsia (FD) is a common functional gastrointestinal disorder in the upper abdomen (above the navel). No drug is approved for this common and distressful condition, and it remains an area of unmet need.
FD can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.5
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 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 and uptake (digestion and absorption), FD has troublesome gastrointestinal symptoms in the upper belly which 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. As mentioned earlier, as 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 nonprescription medical food designed to address the unmet medical need for products to help manage Functional Dyspepsia (FD, or recurring, often meal-triggered indigestion). 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 made available in a solid-state and are then triple-coated. With the patented Site-Specific Targeting® (SST®) technology pioneered by IM HealthScience, FDgard capsules are designed to contain these triple-coated, solid-state microspheres and to have them move intact rapidly through the stomach and then to release the caraway oil and l-Menthol quickly and reliably where they are needed most in FD — the duodenum (upper belly). The l-Menthol helps with smooth muscle relaxation and provides analgesic, anti-inflammatory and anti-gas10 activities.10–13 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.14–16 In addition to caraway oil and l-Menthol, FDgard provides fiber and amino acids (from gelatin protein). These ingredients can 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.17,18 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.19
In a national survey, FDgard achieved the #1 share of gastroenterologist recommendations for Functional Dyspepsia (FD) or meal-triggered indigestion for the third year in a row.†
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 should be used under medical supervision, since it is a medical food.
Nonprescription FDgard is available to patients in the digestive aisle in major retailers nationwide, including most Walmart locations, CVS/pharmacy, Rite Aid, Walgreens, and many grocery stores. It can also be purchased online at Amazon.
About Gastroenterology & Hepatology
Gastroenterology & Hepatology (G&H) is a monthly peer-reviewed journal reaching nearly 18,000 gastroenterologists and hepatologists. G&H provides editorial content encompassing a wide array of topics relevant and useful to the fields of gastroenterology and hepatology, both separately and together. Content is directed by the strong input of today’s top thought leaders in gastroenterology and hepatology, including feature-length review articles and monthly columns consisting of engaging interviews with experts on current issues in inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), hepatology, and endoscopy.
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.
FDgard® is protected by U.S. patents NO: 8,568,776; 8,911,780; 8,895,086; 9,192,583; 9,220,686; 9,393,279; 9,572,782; and 9,717,696. Additional patents are pending in the U.S. and other jurisdictions.
PreMeal Companion™ is pending approval for a registered trademark of IM HealthScience.
Shield of Confidence™ is pending approval for a registered trademark of IM HealthScience.
The information provided here is for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare 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. Statements made in this release rely upon reviews of literature, input from IMH’s advisors, and IMH’s own expertise. There may always be other opinions or emphasis points. Some of the statements from different sources may not mesh with each other. There may be inadvertent inaccuracies that IMH is not aware of. There may be disparate views on the complex pathophysiology of FGIDs (Functional Gastrointestinal Disorders) and on diagnosis and treatment guidelines. Space limitations in this release only allow limited reference to some guidelines or practices which may or may not be fully agreed to by all scientific, medical, or regulatory experts. For any of IMH’s products, this release does not make or have any intent to make drug claims or any comparison or implied claims against FDA approved interventions for FD. Any comments on any products are based on literature reviews and input from IMH’s own advisors. There may be others who have other points of view. Pre-clinical findings do not always correlate with clinical or real-world findings. The reader is urged to check all current information, including the latest website disclosures and/or package inserts, of any of the medical products mentioned here, as information, including government regulations, changes all the time. The statements of individual opinions are those of the individuals quoted and do not necessarily reflect the opinions of IMH. Please fully read all disclaimers/clarifications/explanations. IMH disclaims any injury or alleged injury resulting from any ideas, methods, instructions, or products referred to here. Healthcare practitioners should use their independent, professional judgment in helping their patients best manage their FGID conditions. The company will strive to keep information current and consistent, but may not be able to do so at any specific time. Generally, the latest information on FDgard can be found on the website.
†† Individual results may vary
† IQVIA. ProVoice Survey IBgard Is the #1 Gastroenterologist Recommended Peppermint Oil For Patients with IBS; 2019 [Among gastroenterologists who recommended peppermint oil for IBS]
1. Harer KN, Hasler WL. Functional dyspepsia: A review of the symptoms, evaluation, and treatment options. Gastroenterol Hepatol. 2020;16(2):66-74.
2. Chey WD, Lacy BE, Cash BD, Epstein M, Corsino PE, Shah SM. A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia : A Randomized Controlled Trial. Clin Transl Gastroenterol. 2019;10(4).
3. FDACT (Functional Dyspepsia Adherence and Compliance Trial) - Rapid relief of functional dyspepsia symptoms with a novel formulation of caraway oil and L-menthol: outcomes from a self-reported patient outcomes study - Chey, W. In: American College of Gastroenterology Annual Conference - Orlando, FL. ; 2017.
4. Lacy B, Epstein M, Shah S, Corsino P. 24-month post marketing safety surveillance data of caraway oil and L-menthol with site specific targeting (COLM-SST): a novel formulation for FD. In: American College of Gastroenterology Annual Conference - San Antonio, TX. ; 2019.
5. Lacy BE, Weiser KT, Kennedy AT, Crowell MD, Talley NJ. Functional dyspepsia: the economic impact to patients. Aliment Pharmacol Ther. 2013;38(May):170-177. doi:10.1111/apt.12355
6. Voiosu TA, Giurcan R, Voiosu AM, Voiosu MR. Functional dyspepsia today. Maedica - a J Clin Med. 2013;8(1):68-74. doi:10.1097/00001574-200411000-00007
7. Mahadeva S, Goh KL. Epidemiology of functional dyspepsia: A global perspective. World J Gastroenterol. 2006;7(12):2661-2666. doi:10.3748/wjg.v12.i17.2661
8. Talley NJ. Functional Dyspepsia : Advances in Diagnosis and Therapy. Gut Liver. 2017;11(3):349-357.
9. Lacy BE, Talley NJ, LockeGR 3rd, et al. Current treatment options and management of functional dyspepsia. Aliment Pharmacol Ther. 2012;36(3):3-15. doi:10.1111/j.1365-2036.2012.05128.x
10. Harries N, James KC, Pugh WK. Antifoaming and carminative actions of volatile oils. J Clin Pharm Ther. 1977;2(3):171-177.
11. Juergens UR, Stober M, Vetter H. The anti-inflammatory activity of L-menthol compared to mint oil in human monocytes in vitro: a novel perspective for its therapeutic use in inflammatory diseases. Eur J Med Res. 1998;3(12):539-545.
12. Amato A, Liotta R, Mulè F. Effects of menthol on circular smooth muscle of human colon: Analysis of the mechanism of action. Eur J Pharmacol. 2014;740:295-301. doi:10.1016/j.ejphar.2014.07.018
13. Liu B, Fan L, Balakrishna S, Sui A, Moris JB, Jordt S-E. TRPM8 is the Principal Mediator of Menthol-induced Analgesia of Acute and Inflammatory Pain. Pain. 2013;154(10):2169-2177. doi:10.1016/j.pain.2013.06.043.TRPM8
14. Alhaider A, Al-Mofleh I, Mossa J, Al-Sohaibani M, Rafatullah S, Qureshi S. Effect of Carum carvi on experimentally induced gastric mucosal damage in Wistar albino rats. Int J Pharmacol. 2006;2(3):309-315.
15. Micklefield G, Jung O, Greving I, May B. Effects of intraduodenal application of peppermint oil (WS 1340) and caraway oil (WS 1520) on gastroduodenal motility in healthy volunteers. Phyther Res. 2003;17:135-140. doi:10.1002/ptr.1089
16. Goerg KJ, Spilker T. Effect of peppermint oil and caraway oil on gastrointestinal motility in healthy volunteers: A pharmacodynamic study using simultaneous determination of gastric and gall-bladder emptying and orocaecal transit time. Aliment Pharmacol Ther. 2003. doi:10.1046/j.1365-2036.2003.01421.x
17. May B, Köhler S, Schneider B. Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Aliment Pharmacol Ther. 2000;14:1671-1677. doi:10.1046/j.1365-2036.2000.00873.x
18. Rich G, Shah A, Koloski N, et al. A randomized placebo-controlled trial on the effects of Menthacarin, a proprietary peppermint- and caraway-oil-preparation, on symptoms and quality of life in patients with functional dyspepsia. Neurogastroenterol Motil. 2017;29(May):e13132. doi:10.1111/nmo.13132
19. Madisch A, Heydenreich C, Wieland V, Hufnagel R, Hotz J. Treatment of Functional Dyspepsia with a Fixed Peppermint Oil and Caraway Oil Combination Preparation as Compared to Cisapride - A multicenter, reference-controlled double-blind equivalence study. Arzneimittelforsch Drug Res. 1999;49(II):925-932.