10 Jun FDgard® Combination of Caraway Oil and L-Menthol for Treatment of Functional Dyspepsia

MedicalResearch.com Interview with:

Dr. Chey

William D. Chey, M.D., F.A.C.G.
Director, Division of Gastroenterology
Michigan Medicine Gastroenterology Clinic
Ann Arbor, Michigan

MedicalResearch: What is the background for this study? Would you tell us what is meant by Functional Dyspepsia?

Response: Functional dyspepsia (FD or meal-triggered indigestion) is a very common disorder affecting 11 percent – 29.2 percent of the world’s population, making it comparable in prevalence to Irritable Bowel Syndrome (IBS). However, unlike IBS, there is no FDA approved product to treat FD. Sufferers are often treated off-label with prescribed proton pump inhibitors (PPIs), histamine type-2 receptor antagonists (H2RAs), antidepressants, and prokinetics. While offering relief to a portion of FD patients, some of these have been associated with adverse events. Functional dyspepsia can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.

In functional dyspepsia, which is typically recurring, meal-triggered indigestion with no known organic cause, the normal function and sensation of the stomach and intestines are altered. FD is accompanied by symptoms such as epigastric pain or discomfort, epigastric burning, postprandial fullness, inability to finish a normal sized meal, heaviness, pressure, bloating in the upper abdomen, nausea, and belching. When doctors diagnose FD, they often identify patients as those who have these symptoms for at least three months, with symptom onset six months previously.

Caraway oil and peppermint oil have a history of helping some patients with functional dyspepsia. 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 the intensity of sensations of pressure, abdominal heaviness and fullness significantly better than control

MedicalResearch: What are the main findings?

Response: Clinical and Translational Gastroenterology (CTG), a peer-reviewed medical journal, recently published the U.S. results of an important, double-blind, placebo-controlled study, FDREST™ (Functional Dyspepsia Reduction Evaluation and Safety Trial), which 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.

The study 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 14, 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.

This study had a higher hurdle than previous studies on a similar combination of ingredients. Firstly, 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 the high-symptom burden, 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 first dose, FDgard helped further improve symptoms at 4 weeks in high-symptom burden patients. In all cases, FDgard was safe and well-tolerated.

Results of FDREST were first presented at Digestive Disease Week (DDW), the largest gathering of gastroenterologists, in May 2017.

MedicalResearch: What should readers take away from your report?

Response: This unique study was designed to answer a very important scientific question about the effectiveness, safety, and tolerability of a novel and innovative formulation of caraway oil and l-Menthol designed as solid state, enteric coated microspheres for targeted duodenal release for FD. In patients taking their usual medications for FD, FDgard was found to be effective, safe and well tolerated in rapidly reducing symptoms and in relieving severe symptoms. The positive finding at 24 hours is clinically important as symptoms are often triggered by a meal and patients are looking for rapid relief of those symptoms.

The FDREST™ study results represent a significant contribution to the management of Functional Dyspepsia. FDgard^®, which is the only product available for the dietary management of FD, demonstrated rapid relief of FD symptoms in patients even when used as an add-on therapy to commonly used, off-label medications to treat FD, as demonstrated in the study.

The study also cited the importance of utilizing the microsphere-based site-specific targeting of FDgard (caraway oil and l-Menthol, the active ingredient in peppermint oil) to the duodenum. This site (duodenum) was targeted primarily due to mounting evidence that gastroduodenal mucosal integrity and low-grade inflammation play a role in FD. Furthermore, studies have shown that caraway oil and peppermint oil act on the duodenum to induce smooth muscle relaxation, and that l-Menthol has anti-inflammatory effects. This may help normalize motility effects.

The results highlight an advance in the management of FD, as current off-label medications such as PPIs, H2RAs and antidepressants offer only a modest level of therapeutic gain over placebo and may be associated with adverse events, especially with continued use. FDgard addresses a significant unmet medical need for a product to help manage symptoms in the 1 in 6 adults suffering from this common disorder.”

MedicalResearch: What recommendations do you have for future research as a result of this study?

Response: Larger studies on the effect of FDgard^® in adults with FD will add additional information to our body of knowledge.

MedicalResearch: Is there anything else you would like to add? Any disclosures?

Disclosures: Dr. Chey has served as a consultant to IM Health Science^®, the company that markets FDgard^®.

Response: The novel caraway oil and peppermint oil formulation (COLM-SST) is marketed as FDgard^® and available in most pharmacies nationwide. FDgard^® is specially formulated for the dietary management of FD. It is the first product using a patented, breakthrough technology called Site Specific Targeting (SST^®) to deliver individually triple-coated, solid-state microspheres of caraway oil and l-Menthol, the primary component in peppermint oil, quickly and reliably where they are needed most in FD — the upper belly.

Citation:

The study, 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,” is now available to the public via open access on the Clinical and Translational Gastroenterology website. Clinical and Translational Gastroenterology, published on behalf of the American College of Gastroenterology (ACG), is dedicated to innovative clinical work in the field of gastroenterology and hepatology.

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Last Updated on June 10, 2019 by Marie Benz MD FAAD