Final Results Of Real-World Data From Observational Study Underscores High Levels Of Patient Satisfaction And Rapid Improvement Of Functional Dyspepsia (Recurring Indigestion) With Non-Prescription FDgard®

ORLANDO, Fla., Oct. 18, 2017 /PRNewswire/ -- IM HealthScience^® (IMH) today announced complete and final results of FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), a real-world observational study of 600 patients who took FDgard^®, the only available, non-prescription medical food specially formulated for the dietary management of Functional Dyspepsia (FD). The main results from FDACT™ were  presented by William D. Chey, M.D., F.A.C.G., Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, at the World Congress of Gastroenterology at ACG 2017 in Orlando, Florida. Dr. Chey's oral presentation took place on Tuesday, October 17, at 8:30am (Location: Orange County Convention Center, Simultaneous Plenary Session 2B, Valencia Ballroom D). 

The findings from the real-world, observational study, FDACT™, and a previously presented landmark, multi-centered, post-marketing, parallel group, U.S.-based study, FDREST™, both revealed rapid relief of FD symptoms and a high level of overall symptom satisfaction.¹

FD has been characterized as recurring indigestion with no known organic cause and is an area of high unmet medical need. FD remains poorly recognized and presents a significant management challenge for providers and patients. Gastrointestinal symptoms can include epigastric pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating and belching.  Currently, there are no approved drugs for FD. Off-label medications are used to treat the condition and patient dissatisfaction remains high.²

"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 and symptom improvement for many patients with functional dyspepsia – a condition for which there are few effective treatments."

Data from FDACT™ showed that there was a high level of patient satisfaction and overall symptom relief with the product. Study results showed:

• 95 percent of patients reported major or moderate improvement in their overall symptoms of FD:
• 92.5 percent of patients with Epigastric Pain Syndrome (EPS, which is epigastric pain or burning) indicated improvement in their upper abdominal pain after taking FDgard^®.  
• 86.5 percent of patients with Postprandial Distress Syndrome (PDS, which is early fullness, pressure and heaviness) indicated that their relief from fullness was attained in two hours or less after taking FDgard^®. 
• 86.4 percent of patients indicated experiencing relief from symptoms within 2 hours after taking FDgard^®.

Additionally, the data showed:

• 91.2 percent of patients take between 1 and 4 capsules per day, and
• 56.2 percent of patients take FDgard^® before meals.

About FDACT™
FDACT™ (Functional Dyspepsia Adherence and Compliance Trial) was a real-world observational study of 600 patients taking FDgard^®. The survey collected information on frequency of FD symptoms, daily consumption of capsules, onset of action, improvement in FD symptoms, quality of life and patient satisfaction with the product. Patients were asked via cards in FDgard^® samples distributed through physician offices to www.FDgardoffers.com to complete a 10-question online survey. The results were from data collected between May 1, 2016, and May 15, 2017.

About FDREST™ 
The findings from the real-world, observational study, FDACT™, and a previously presented landmark, multi-centered, post-marketing, parallel group, U.S.-based study, FDREST™, revealed a consistently high level of patient satisfaction and rapid relief of FD symptoms. In FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial), the study showed that patients with FD who received FDgard^® versus placebo plus commonly used, off-label FD medications experienced a statistically significant reduction in Postprandial Distress Syndrome (PDS) symptoms (early satiety, abdominal heaviness, pressure and fullness) and near statistical significance in Epigastric Pain Syndrome (EPS) symptoms (epigastric pain or discomfort and burning) 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.

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 had substantial symptom (clinical global) improvement vs. approximately half in the control arm.

About Functional Dyspepsia (FD)
About one in six Americans have Functional Dyspepsia.³ This condition can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.⁴

In FD, which is recurring indigestion with no known organic cause, 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.

About FDgard® 
FDgard^® is nonprescription medical food designed to address an unmet medical need for products to help in managing FD 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.^5,6,7 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.

The usual adult dose of FDgard^® is 2 capsules, as needed, up to two times a day, not to exceed six capsules per day. Many physicians are now recommending taking FDgard^® before a meal, as it enables the supportive effect of FDgard^® to start as early as possible. 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 ACG
Founded in 1932, the American College of Gastroenterology (ACG) is an organization with an international membership of more than 14,000 individuals from 85 countries. The College's vision is to be the pre-eminent professional organization that champions the evolving needs of clinicians in the delivery of high-quality, evidence-based and compassionate health care to gastroenterology patients. The mission of the College is to advance world-class care for patients with gastrointestinal disorders through excellence, innovation and advocacy in the areas of scientific investigation, education, prevention and treatment. www.gi.org. Follow ACG on Twitter @AmCollegeGastro.

About WGO
Formed in 1935 and incorporated in 1958, the World Gastroenterology Organization (WGO) is a federation of over 100 Member Societies and 4 regional associations of gastroenterology, hepatology, and other related disciplines representing more than 50,000 individual members worldwide, focusing on the improvement of standards in gastroenterology training and education on a global scale. The WGO Foundation, incorporated in 2007, is dedicated to raising funds to support WGO educational programs and activities. To learn more about the WGO, visit their website, worldgastroenterology.org

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 modified-release 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.

¹ Chey, W.D. (2017, October). Rapid Relief of Functional Dyspepsia Symptoms With a Novel Formulation of Caraway Oil and L-Menthol: Outcomes From a Self-Reported Patient Outcomes Study. Simultaneous Plenary Session 2B, Program No. 32 Meeting Abstract, conducted at the World Congress of Gastroenterology at ACG 2017, Orlando, Florida.

² 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.

³ Talley, N.J. (2017, May). Functional Dyspepsia: Advances in Diagnosis and Therapy. Gut and Liver, 11(3), 349-357. doi:  10.5009/gnl16055.

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.

⁵ 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. 

⁶ Sun, J. (2007). D-Limonene: Safety & Clinical Applications. Alternative Medicine Review, 12 (3): 259-264.

⁷ 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.

SOURCE IM HealthScience

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