INTERIM RESULTS OF REAL-WORLD DATA FROM OBSERVATIONAL STUDY DEMONSTRATE HIGH LEVELS OF PATIENT SATISFACTION AND RAPID IMPROVEMENT OF FUNCTIONAL DYSPEPSIA (PERSISTENT OR RECURRING INDIGESTION) WITH NEW NON-PRESCRIPTION FDgard®

  • Functional Dyspepsia (FD), known for its symptoms of persistent or recurring indigestion, impacts an estimated 1 in 6 adults in the U.S.
  • Rapid symptom improvement reported by patients taking FDgard®
  • Patients reported high overall level of satisfaction and enhanced quality of life while taking FDgard®
  • Fast relief of symptoms is emerging as an important attribute of FDgard®
  • 80 percent of patients reported suffering FD on a daily basis

Las Vegas, Nev. and Boca Raton, Fla. – (October 17, 2016) – IM HealthScience® (IMH) today announced interim results of FDACT™ (Functional Dyspepsia Adherence and Compliance Trial), a real-world observational study of 205 patients who took FDgard®, a new, non-prescription medical food specially formulated for the dietary management of Functional Dyspepsia (FD). FD has been characterized as persistent or recurring indigestion with no known organic cause. Currently, there are few options for doctors and their patients to manage FD.

Interim data from FDACT™ showed that there was a high level of patient satisfaction with the product even among those patients taking several capsules on a daily basis. More than 92 percent of patients reported major or moderate improvement in their symptoms of FD (persistent or recurring indigestion) while 87 percent of patients indicated that their relief from indigestion was attained in two hours or less after taking FDgard®.

“Functional dyspepsia (FD) can have a significant impact on one’s quality of life,” said Matthew Soff, M.D, a practicing gastroenterologist, affiliated with Westside Regional Medical Center in Plantation, Florida, and North Shore Medical Center in Ft. Lauderdale, Florida. “There are newly published criteria to help physicians diagnose FD, but up until now, treatment options have been limited, with few effective agents. In my experience, FDgard® has been a great addition for fast relief of frustrating FD symptoms. This natural product effectively controls the upper abdominal pain, the feeling of early fullness with a meal, and the nausea, belching and bloating that are so bothersome to FD patients. When physicians discuss the treatment of FD with their patients, FDgard® should be strongly considered. As a gastroenterologist with 36 years of experience, I appreciate having this effective, non-prescription option for my FD patients. FDgard®, an effective, over-the-counter natural agent with the safety profile of peppermint, has answered the prayers of many patients and their physicians. The excellent results I am seeing have truly exceeded my expectations.”

Importantly, patients showed improvement of the two hallmark symptoms of FD, which is upper abdominal pain and early fullness. About 92 percent of patients reported a major or moderate improvement in their upper abdominal pain, while close to 90 percent of patients reported major or moderate improvement in their feeling of fullness.

About Functional Dyspepsia (FD)
Approximately 30 percent of adults suffer from dyspepsia, and about half are estimated to have FD, or non-ulcer dyspepsia.1 In FD, the normal digestive processes may be disrupted as well as 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 customarily identify patients as follows: patients should have these symptoms for at least three months with symptom onset six months previously. This condition can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.2

About FDACT™
FDACT™ (Functional Dyspepsia Adherence and Compliance Trial) was a real-world observational study of 205 patients taking FDgard®. The survey collected information on dosing frequency, onset of action and satisfaction with the product. Patients were asked via cards in FDgard® samples distributed through physician offices to www.FDgardoffers.com to complete a survey. The interim results were from data collected between May 2016 and September 2016.

Data from FDACT™ will continue to be collected with final results reported in 2017.

Interim Results Show Significant Improvement and Patient Satisfaction
In patients taking FDgard®, the FDACT™ data showed that 8 out of 10 patients suffer from FD symptoms daily. Key interim findings from the FDACT™ report included:

  • More than 92% reported major or moderate improvement of their indigestion;
  • About 92% of patients reported a major or moderate improvement in their upper abdominal pain;
  • Close to 90% of patients reported major or moderate improvement in their feeling of fullness;
  • About 89% of patients reported a major or moderate improvement in their quality of life; and
  • 87% of patients felt relief of their indigestion within 2 hours of taking FDgard®

Additionally, patients taking FDgard® were asked how likely they were to recommend FDgard® and to continue taking FDgard®:

  • About 94% reported they were very likely or likely to recommend FDgard® to family or friends who have FD; and
  • More than 96% reported that they were very likely or likely to continue taking FDgard® for their FD.

About FDgard®
FDgard® is 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 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 helps to normalize gallbladder function as well as deliver promotility and analgesic action in the small intestine (the duodenum) and the stomach. 3 4 5 In addition to caraway oil and l-Menthol, FDgard® also provides fiber and protein.

Caraway oil and peppermint oil have a history of working in FD. Until now, targeted delivery to the upper belly has posed a challenge. 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. While FDgard® does not require a prescription, it must be used under medical supervision. FDgard® is available in the digestive aisle of most CVS/pharmacy and Walgreens stores nationwide.

About IM HealthScience®
IM HealthScience® (IMH) is the innovator of FDgard®. It is a privately held company based in Boca Raton, Florida, that is also the innovator of IBgard® for the dietary management of irritable bowel syndrome. 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.

 

1 Copyright © 1997 International Foundation for Functional Gastrointestinal Disorders (IFFGD). All rights reserved. Functional Dyspepsia and IBS: Incidence and Characteristics.

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 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.

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

5 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.