Real-World Data From Surveillance Study At 12 Months Confirms Excellent Safety And Tolerability Profile Of New, Non-Prescription FDgard® For Functional Dyspepsia

BOCA RATON, Fla., Aug. 24, 2017 /PRNewswire/ -- IM HealthScience^® (IMH) today announced favorable results from its Functional Dyspepsia Safety Update at 12 months (FDSU-12), a real-world, post-marketing surveillance study reporting on the safety and tolerability profile of FDgard^® among an estimated 392,554 patients who used the product. The results found no serious adverse events. Additionally, the rates and patterns of non-serious adverse events were low (0.014 percent or 57 people out of 392,554 patients studied) and generally consistent with those normal adverse events commonly associated with an FD population. These non-serious adverse events included dyspepsia, rash, headache and abdominal pain.

The FDSU-12 captured and analyzed serious and non-serious adverse event reports for FDgard^® over a twelve-month period from July 8, 2016, to July 8, 2017.

FDgard^® is a non-prescription medical food specially formulated for the dietary management of Functional Dyspepsia (FD). FD is often characterized as persistent or recurring indigestion with no known organic cause.  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 and off-label medications are used to treat the condition.  

"Functional dyspepsia can have a significant impact on one's quality of life," said Michael S. Epstein, M.D., F.A.C.G., A.G.A.F., a leading gastroenterologist and Chief Medical Advisor for IM HealthScience^®. "The findings from FDSU-12 reaffirm the safety and tolerability profile of FDgard^® in real-world settings and are very reassuring. FDgard^® is an effective and well-tolerated option in the management of patients with FD where few options are available."

About FDSU-12
The Functional Dyspepsia Safety Update at 12 months (FDSU-12) is a real-world, post-marketing surveillance study reporting on the safety and tolerability profile of FDgard^® among an estimated 392,554 patients who used the product. An independent call center was retained with pharmacovigilance-trained health care personnel in accordance with U.S. Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events and to receive and record FDgard^® customer questions, product issues and adverse events. The adverse events for this study were collected and processed from July 8, 2016, to July 8, 2017. An analysis of data by reviewers showed that there were no serious adverse events associated with the use of FDgard^® during this time frame. Only 57 patients reported non-serious adverse events, out of an estimated 392,554 patients who used FDgard^® during this period. The adverse event rate of 0.014 percent was low and the reviewers believed it was difficult to separate these adverse events from the normal adverse events commonly associated with an FD population. In fact, dyspepsia was the most reported non-serious adverse event which is the underlying condition being treated for in this patient population taking FDgard^®.

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 This condition can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.²

In FD, 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, postprandial fullness, abdominal heaviness and pressure, 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 a non-prescription 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.^{3 4 5} In addition to caraway oil and l-Menthol, FDgard^® also provides fiber and amino acids (from gelatin protein). These ingredients have additional positive effect on the gut wall and this helps 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. Targeted delivery to the upper belly is desirable and now, with SST^®, this has now become possible.

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 (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 arm⁶.

There were no serious adverse events in the FDREST™ clinical study.

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.

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.

⁶ Chey, W.D., Lacy, B.E., Cash, B.D., Epstein, M.S., & Shah, S. (2017, May). 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. Poster session presented at the Digestive Disease Week meeting, the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery, Chicago, IL.

SOURCE IM HealthScience

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