FDgard® Demonstrated Rapid Relief of Symptoms in Functional Dyspepsia

MedicalResearch.com Interview with:

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

Dr. Chey

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

MedicalResearch.com: What is the background for this study?

Response: Functional Dyspepsia (FD), which is persistent or recurring upper abdominal pain, burning, or fullness with no known organic cause, is a relatively common and often frustrating condition. The precise causes of this condition are unknown, but problems with mild inflammation, leakiness of the lining of the gut, overactive sensation, and abnormal contractions of the upper digestive tract are thought to play a role in many patients. FD often reoccurs over time and it is an area of high unmet medical need.

Functional Dyspepsia can have a significant impact on quality of life. Currently, off-label medications are used to treat FD, as there is no U.S. Food and Drug Administration (FDA)-approved pharmaceutical product for the condition.

An estimated 62 percent of FD patients suffer from Epigastric Pain Syndrome (EPS, which is epigastric pain or burning), while an estimated 73 percent of FD patients suffer from Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness); 35 percent suffer from both.

In this study, we compared the efficacy of a unique encapsulated formulation of caraway oil and l-Menthol, the primary component in peppermint oil), (COLM-SST) to placebo in patients taking their usual Functional Dyspepsia medications. Caraway oil contains carvone and d-limonene, which have gastroprotective and prokinetic effects; l-Menthol has anti-inflammatory, prokinetic, analgesic and gastroprotective effects.

MedicalResearch.com What are the main findings?

Response:  A multi-centered, post-marketing, parallel group, U.S-based study, entitled FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial), showed that patients with FD who received FDgard® versus a control arm of placebo plus commonly used, off-label FD medications experienced a statistically significant reduction in PDS symptoms and near statistical significance in EPS symptoms at 24 hours.

Some of our top-line findings from the data, which were presented in three posters at the recent Digestive Disease Week meeting in Chicago included:
• FDgard® demonstrated symptom reduction and rapid relief of FD symptoms in patients at 24 hours.
• FDgard® showed effective symptom reduction and rapid relief of FD symptoms in a sub-group of FD patients with EPS and PDS.
• FDgard® as an add-on product improved FD symptoms in patients already using other off-label medications prescribed for FD, such as proton pump inhibitors (PPIs) and histamine receptor 2 antagonists (H2RAs), anticonvulsants, antibiotics, antihistamines, antidepressants, and antacids as rescue medications.
• The study also showed an improvement in the Clinical Global Impressions (CGI) Scale, a physician-administered measure of symptoms severity, treatment response and treatment efficacy. At 4 weeks, approximately 75 percent of the EPS and PDS patients in the FDgard® arm reported substantial symptom improvement vs. approximately half in the control arm.
Analysis of FDREST™ data showed that treatment with FDgard® resulted in:

Change in EPS and PDS Symptoms In PDS Group at 24 hours:
• 19.5% reduction of EPS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0121).
• 15.8% reduction of PDS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0225).

Change in EPS and PDS Symptoms In EPS Group at 24 hours:
• 20.7% reduction of EPS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0028).
• 13.2% reduction of PDS symptoms from baseline at 24 hours. Statistically significant compared to the control (P=0.0186).

Change in the Clinical Global Impressions Scale (CGI, a measure of symptom severity, treatment response and treatment efficacy):

• At the end of treatment, 77.7% of PDS patients and 72.2% of EPS patients reported either a “much” or “very much” improved assessment of the Clinical Global Impressions (CGI) scale, compared to 50% (P=0.09) and 40% (P=0.046) in the control groups, respectively.

MedicalResearch.com What should readers take away from your report?

Response:  The FDREST™ study results represent a significant contribution to the management of Functional Dyspepsia. We believe that FDgard®, which is the only product available for the dietary management of Functional Dyspepsia, demonstrated rapid relief of  Functional Dyspepsia 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. In particular, many FD symptoms flare within 2 hours after a meal, so the fast action seen in this FDgard® study is an important advance.

MedicalResearch.com: 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.com: Any disclosures?
Disclosures: Dr. Chey has served as a consultant to IM Health Science®, the company that markets FDgard®.
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:
DDW 2017  Posters

• Randomized Controlled Trial to Assess the Efficacy & Safety of Caraway Oil/L-Menthol plus Usual Care Polypharmacy vs. Placebo plus Usual Care Polypharmacy for Functional Dyspepsia
• A caraway oil/menthol combination improves functional dyspepsia (FD) symptoms within the first 24 hours: Results of a randomized controlled trial, which allowed usual FD treatments
• Efficacy of caraway oil/L-menthol plus usual care vs placebo plus usual care, in functional dyspepsia patients with post-prandial distress (PDS) or epigastric pain (EPS) syndromes: Results from a US RCT.

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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