Gail S. Thornton
West Mill Consulting
EMBARGOED UNTIL SATURDAY, MAY 6, 2017, 9:30am (Central Time)
POSTER #’s: Sa1618, Sa1619, Sa1620
RESULTS OF NEW CLINICAL DATA PRESENTED AT DIGESTIVE DISEASE WEEK (DDW), A PREMIER GASTROENTEROLOGY MEETING, SHOW UNPRECEDENTED SYMPTOM REDUCTION AND RAPID RELIEF OF FUNCTIONAL DYSPEPSIA (FD – PERSISTENT OR RECURRING INDIGESTION) WITH FDgard®, A NEW PRODUCT FOR THIS CONDITION
- First-ever clinical study highlights an advance in the management of Functional Dyspepsia (FD) with FDgard®, a new, non-prescription medical food specially formulated for the dietary management of FD
- In FD patients, FDgard® significantly reduced symptoms of FD in as early as 24 hours
- Data showed FDgard®, as an add-on product, improved FD symptoms in patients already using commonly used, off-label medications prescribed for FD
- Functional Dyspepsia, known for its symptoms of persistent or recurring indigestion, impacts an estimated 1 in 6 adults in the U.S.
- This medical advance is important because there are no approved products for FD
CHICAGO – (May 8, 2017) – Landmark clinical data highlight an advance in the management of Functional Dyspepsia (FD) with FDgard®, the only product available for the dietary management of FD. FDgard® demonstrated unprecedented symptom reduction and rapid relief of FD symptoms in patients in only 24 hours. This data was presented during Digestive Disease Week (DDW), a premier gastroenterology meeting.
FDgard® showed effective symptom reduction and rapid relief of FD symptoms in a sub-group of FD patients with Epigastric Pain Syndrome (EPS, which is epigastric pain or burning) and Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness). Additionally, the study findings showed that FDgard® as an add-on product improved FD symptoms in patients already using commonly used, 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 (permitted no more than three doses per week).
FD is often characterized as persistent or recurring indigestion with no known organic cause and is an area of high unmet medical need. 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.
Data from the landmark, 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 Postprandial Distress Syndrome (PDS) symptoms and near statistical significance in Epigastric Pain Syndrome (EPS) symptoms at 24 hours. In spite of the polypharmacy and use of rescue medications after 48 hours of first dose, FDgard® helped further improve symptoms at 4 weeks.
Specifically, the FDREST™ study showed that at 24 hours, FDgard® improved FD symptoms in patients and provided rapid and significant reduction in EPS and PDS symptoms in the PDS sub-group as well as a statistically significant reduction in EPS and PDS symptoms in the EPS sub-group. 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.
An estimated 62 percent of FD patients suffer from EPS, while an estimated 73 percent of FD patients suffer from PDS. The overlap of EPS and PDS, which are those FD patients who suffer from both syndromes, is estimated to be 35 percent.
FDgard® is specially formulated for the dietary management of FD, which is persistent or recurring indigestion. 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.
The three posters with data from the FDREST™ study were selected for presentation at DDW on Saturday, May 6, 2017.
“These study results are uniquely important and represent an advance in the management of Functional Dyspepsia,” said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®. “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 even when used as an add-on therapy to commonly used, off-label medications to treat FD, as demonstrated in the FDREST™ 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.”
“Functional dyspepsia can have a significant impact on a patient’s quality of life,” said
William D. Chey, M.D., F.A.C.G., the lead study author and Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, Michigan. “These study results suggest that FDgard® can provide rapid relief to a subset of patients with functional dyspepsia – a condition for which there are few effective treatments.”
Analysis of FDREST™ data showed that treatment with FDgard® resulted in:
Change in Epigastric Pain Syndrome (EPS) and Postprandial Distress Syndrome (PDS) Symptoms In Overall Participants at 24 hours:
- 14% improvement of EPS symptoms from baseline at 24 hours. Close to statistical significance compared to the control group (P=0.0737).
- 9.9% reduction of PDS symptoms from baseline at 24 hours. Statistically significant compared to the control group (P=0.0393).
Change in Epigastric Pain Syndrome (EPS) and Postprandial Distress Syndrome (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 Epigastric Pain Syndrome (EPS) and Postprandial Distress Syndrome (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.
- EPS patients had a statistically significant reduction in epigastric pain or discomfort symptoms at 24 hours and were objectively better, although measures did not reach statistical significance, compared to the control group, in all measures at 2-14 days and 15-28 days.
- PDS patients had a statistically significant reduction in sensations of pressure, heaviness, or fullness compared with the control group at 24 hours and were objectively better, although measures did not reach statistical significance, compared to the control group, in all measures at 2-14 days and 15-28 days.
FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial) was a multi-centered, post-marketing, parallel group, U.S-based study conducted at eight university-based or gastroenterology research-based centers in the U.S. (study period July 1, 2015, to September 14, 2016). The study was designed to compare the efficacy and safety of FDgard®, plus commonly used FD medications vs a control group of placebo plus commonly used, off-label medications prescribed for FD.
- There were 100 study participants (76% female; 24% male), aged 18-60 (mean age 43.4 years), with symptoms of FD, all of whom met Rome III criteria for FD.
- They were selected if they met one or both of the following criteria, based on symptoms:
- Postprandial Distress Syndrome (PDS, early fullness, pressure and heaviness) – Bothersome postprandial fullness or early satiation at least 3 days per week
- Epigastric Distress Syndrome (EPS, epigastric pain or burning) – Bothersome epigastric pain or burning at least 1 day per week.
- They had to have at least moderate symptoms (≥4 points on either question of the 7-point Global Overall Symptoms (GOS) scale on at least 4 days during a 14-day screening period. The GOS scale is a self-reported 7-point scale, adapted from a previously validated 5-point scale. With this scale, patients are asked to grade the overall severity of their dyspepsia symptoms, as defined as upper abdominal symptoms over a certain period of time.
- The study also showed an improvement at 4 weeks in the Clinical Global Impressions (CGI) Scale, a physician-administered measure of symptom severity, treatment response and treatment efficacy.
- In the trial, study participants took two capsules of FDgard® or matching placebo in the morning and at dinner time 30 to 60 minutes before a meal. FDgard® or placebo was added to each patients existing FD medication regimen, which included proton pump inhibitors (PPIs), histamine receptor 2 antagonists (H2RAs), anticonvulsants, beta blockers, antihistamines, antidepressants/tricyclic antidepressants (TCAs), pain modulators, antacids, and/or antibiotics. In addition, rescue medications (including prokinetics, antiemetics, anticholinergics, laxatives, antidiarrheals, misoprostol, oral antibiotics, probiotics, calcium channel antagonists, NSAIDs, aspirin (>81 mg per day), antispasmodics, narcotic analgesics, sedative hypnotic agents and other medications that may affect the study) were allowed 48 hours after the first dose, if approved by the medical monitor.
- Over the course of the study, no serious treatment-emergent adverse events were reported.
About Functional Dyspepsia (FD)
Approximately 30 percent of adults suffer from dyspepsia, and about half are estimated to have FD, or non-ulcer dyspepsia. This condition can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.
In FD, which is persistent or recurring indigestion, the normal digestive processes are disrupted along with 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 often identify patients as follows: patients should have these symptoms for at least three months with symptom onset six months previously.
FDgard® is medical food designed to address an unmet medical need for products to help in managing FD, which is persistent or recurring 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.   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. A randomized, placebo-controlled multicenter study in Europe, previously conducted with the same endpoints and measurements as used in FDREST™, had shown the effectiveness of caraway oil and peppermint oil (l-Menthol) in managing FD symptoms. This study was rated as the highest-quality study on the Jadad scale with a rating of 5, which independently assesses the methodological quality of a clinical trial, and is the most widely used assessment in the world. The study had used the older single-unit, oil-filled capsule technology, which has challenges in rapid and targeted delivery. Targeted delivery to the upper belly is desirable as recent studies have identified this as the area of disturbance in FD. With SST®, it has now become possible to deliver the combination of caraway oil and peppermint oil (l-Menthol) to this site.
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, since it is a medical food. FDgard® is available to patients in the digestive aisle at most Rite Aid, CVS/pharmacy and Walgreens stores nationwide.
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. It 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 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.IBgard.com or www.FDgard.com.
Data Presented at DDW Poster Session on Functional Dyspepsia, Nausea and Vomiting
Saturday, May 6, 2017
- (Poster Session #Sa1618) 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
- William Chey, Dr. Brian Lacy, Dr. Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah
- (Poster Session #Sa1620) 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
- Brian Lacy, Dr. William Chey, Dr. Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah
- (Poster Session #Sa1619) 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
- William Chey, Dr. Brian Lacy, Dr. Brooks Cash, Dr. Michael Epstein and Dr. Syed Shah
For more information about featured studies, as well as a schedule of availability for featured researchers, please visit www.ddw.org/press.
About Digestive Disease Week® (DDW)
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 takes place May 6-9, 2017, at McCormick Place, Chicago, IL. 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.
Regulation of Medical Foods
FDgard® is a medical food product and not a drug or dietary supplement. A medical food is defined by section 5(b)(3) of the Orphan Drug Act (21 U.S.C, 360ee (b)(3) as a “food which is formulated to be consumed or administered internally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on scientific principles, are established by medical evaluation.” Medical foods do not require prior approval by the FDA and are in a unique category separate from drugs or dietary supplements. Medical foods must contain ingredients that are “Generally Recognized As Safe” (GRAS), or are approved food additives, as defined under sections 201(s) and 409 of the Federal Food, Drug and Cosmetic Act.
1Talley, N.J. & Ford, A.C. (2015). Functional Dyspepsia. The New England Journal of Medicine, 373, 1853-63. doi: 10.1056/NEJMra1501505.
2 Copyright © 1997 International Foundation for Functional Gastrointestinal Disorders (IFFGD). All rights reserved. Functional Dyspepsia and IBS: Incidence and Characteristics.
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.
7 May, B., Köhler, S., & Schneider, B. (2000). Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Alimentary Pharmacology and Therapeutics, 14 (12), 1671–1677. doi: 10.1046/j.1365-2036.2000.00873.x.