In The Longest-Running Post-Marketing Surveillance Study Of Its Type, Data At 24 Months On FDgard®, Presented At The American College Of Gastroenterology (ACG) Annual Meeting

SAN ANTONIO, Oct. 29, 2019 /PRNewswire/ -- IM HealthScience^® (IMH^®) today announced favorable results from the longest-running post-marketing surveillance study of its type. This study, called Functional Dyspepsia Safety Update at 24 months (FDSU24), is a real-world surveillance study reporting on the safety and tolerability profile of FDgard^® (COLM-SST^®). Using patented Site-Specific Targeting^® (SST^®) technology pioneered by IM HealthScience, FDgard is designed to rapidly deliver solid-state, individually triple-coated microspheres of caraway oil and l-Menthol to the duodenum, or upper belly, where they are needed most for the management of Functional Dyspepsia (FD, or recurring, meal-triggered indigestion).

The results were presented by Michael S. Epstein, M.D., FACG, AGAF, one of the study authors, during ACG 2019, the American College of Gastroenterology's Annual Scientific Meeting and Postgraduate Course. Dr. Epstein is a leading gastroenterologist and Chief Medical Advisor for IM HealthScience. ACG is the preeminent professional organization that works on delivering evidence-based health care to gastroenterology patients through scientific investigation, education, prevention, and treatment.

About FDSU24 Study
An analysis of the 24-month, post-marketing safety surveillance data for FDgard^®, called Functional Dyspepsia Safety Update at 24 months (FDSU24), showed that:

• An estimated 558,300 individual patients used the product since the beginning of this surveillance.
• No serious adverse events were reported.
• The self-reporting rate of non-serious adverse events was low, with only 148 events received (from 127 patients) for a total rate of 0.0265%.
• The most commonly reported non-serous events included dyspepsia (10), headache (9), abdominal discomfort (7), abdominal distention (7) and abdominal pain (7). Most of these are difficult to separate from the common presenting symptoms of FD.

"In reconfirming the previous excellent safety profile seen at 6 months in FDSU6 and at 12 months in FDSU12, the results of FDSU24 provide conclusive real-world evidence of the promise of this specially formulated product and its two food extract-based components for patients with Functional Dyspepsia," said Dr. Epstein. "The findings from FDSU24 conclusively reaffirm the safety and tolerability profile of FDgard as an effective, safe, and well-tolerated option in the management of Functional Dyspepsia, where few options are available."

"FDgard is a specially formulated medical food whose components are known to possess anti-inflammatory,^10,11 analgesic¹² and gastroprotective^13,14 properties," said Dr. Epstein. "Not only can FD patients make progress toward normalizing their nutrient intake and uptake, but they now also can deal with the anticipatory anxiety of FD symptoms by taking FDgard before their meals."

FDSU24 captured and analyzed adverse event reports (both non-serious and serious) for FDgard over a 24-month period from July 8, 2016 to July 8, 2018. An independent call center staffed with pharmacovigilance-trained health care personnel in accordance with U.S. Food and Drug Administration (FDA) and global regulatory guidelines on properly reporting events, was retained to receive and record FDgard customer questions, product issues, and adverse events.

Increasing Evidence of the Safety and Efficacy of FDgard^®
FDREST™ (Functional Dyspepsia Reduction and Evaluation Safety Trial) was a multi-centered, post-marketing, parallel-group, U.S.-based study conducted at seven university-based or gastroenterology research-based centers (study period July 1, 2015 to September 1, 2016). The study was designed to compare the efficacy, safety, and tolerability of FDgard^® plus commonly used, off-label medications for FD vs. a control group of placebo plus commonly used, off-label medications prescribed for FD.

The FDREST study demonstrated that patients who took COLM-SST^® (FDgard) on a daily and proactive basis 30 to 60 minutes before meals, along with commonly used off-label FD medications, compared to patients who took placebo along with commonly used off-label FD medications, experienced a statistically significant, rapid reduction of FD symptoms within 24 hours across the FD study population.

This study had a higher hurdle than previous studies on a similar combination of ingredients. First, concomitant medications for FD symptoms were allowed in order to assess FDgard in a real-world setting. Second, only a subgroup of patients in FDREST was categorized into a high-symptom burden subgroup, while they constituted the entire groups in previous studies. Among this subgroup of patients with the high-symptom burden, FDgard showed efficacy at 24 hours. In spite of the polypharmacy and use of rescue medications for FD after 48 hours of the first dose, FDgard helped further improve symptoms at four weeks, especially in those high-symptom burden patients. In all cases, FDgard was safe and well-tolerated.

Underscoring the importance of FDgard as a medical advance, Clinical and Translational Gastroenterology (CTG), a peer-reviewed journal, has published the results of FDREST. The article was entitled "A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial." Dr. William D. Chey, M.D., FACG, Director in the Division of Gastroenterology, Michigan Medicine Gastroenterology Clinic, Ann Arbor, and a globally recognized gastroenterology-science leader, was the lead author of the article.

In addition to FDREST, FDgard has been validated in a real-world patient-reported outcomes trial, called FDACT™ (Functional Dyspepsia Adherence and Compliance Trial).⁶ Complete and final results from FDACT, a study of 600 patients who took FDgard, were peer-reviewed and then selected for an oral presentation session delivered by William D. Chey, M.D., FACG, at the World Congress of Gastroenterology at ACG 2017 in Orlando, Fla. The data showed a consistently high level of patient satisfaction and rapid improvement of FD symptoms with the product. A majority of patients (95 percent) reported major or moderate improvement in their overall FD symptoms, while many patients (86.4 percent) indicated experiencing relief from symptoms within two hours after taking FDgard. The findings from FDACT substantiate those data reported from previous peer-reviewed poster presentations of the randomized clinical trial (FDREST).^3–5

About Functional Dyspepsia (FD)
Functional Dyspepsia (FD) is a common functional gastrointestinal disorder in the upper abdomen (above the navel). The estimated prevalence is 10-30% worldwide. Since no drug is approved for FD, doctors prescribe drugs on an off-label basis. Proton pump inhibitors (PPIs) are commonly prescribed as empiric treatment off-label. There are concerns about their long-term use.  Also, other off-label drug categories used for FD are Histamine Type-2 Receptor Antagonists (H2RAs), antidepressants, and prokinetics.

FD can have a negative effect on workplace attendance and productivity, with associated costs estimated in excess of $18 billion annually.¹⁵

As mentioned earlier, FD has been characterized as recurring, often meal-triggered indigestion, with no known organic cause. About one in six Americans has Functional Dyspepsia.^7–9 It remains an area of high unmet medical need. FD remains under-diagnosed and under-treated and presents a significant management challenge for providers and patients. In addition to being associated with disturbances in nutritional intake and uptake (digestion and absorption), troublesome FD gastrointestinal symptoms in the upper belly can include, at various times, one or all of the following: abdominal pain or discomfort, inability to finish a normal-sized meal, heaviness, pressure, nausea, bloating, and belching. As mentioned earlier, as there are no approved drugs for FD, off-label Rx drugs are used to treat the condition, and patient dissatisfaction remains high.¹⁵ 

About FDgard^® 
FDgard^® is a nonprescription medical food designed to address the unmet medical need for products to help manage Functional Dyspepsia (FD, or recurring, often meal-triggered indigestion) and its accompanying symptoms.  FDgard capsules contain caraway oil and l-Menthol, the primary component in peppermint oil, for the dietary management of FD. These two main ingredients are specially formulated to be made available in a solid-state and are then triple-coated.  With the patented Site-Specific Targeting^® (SST^®) technology pioneered by IM HealthScience, FDgard capsules are designed to contain these triple-coated, solid-state microspheres, and to have them move intact rapidly through the stomach and to then release the caraway oil and l-Menthol quickly and reliably where they are needed most in FD — the duodenum, or upper belly. The l-Menthol helps with smooth muscle relaxation and provides analgesic and anti-inflammatory activities.^10,16,17 Caraway oil helps mitigate the effect of gastric acid on the stomach wall, helps to normalize gallbladder function, and may help to normalize motility in the small intestine (primarily the duodenum) and the stomach.^18–20 In addition to caraway oil and l-Menthol, FDgard 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.^21,22 Cisapride, no longer an FDA-approved pro-motility drug after its removal from the market in 2000 due to cardiovascular side effects, was shown to have efficacy similar to a caraway oil/peppermint oil formulation.²³

In a recent national survey, FDgard achieved the #1 share of gastroenterologist recommendations for Functional Dyspepsia (FD) or meal-triggered indigestion for the third year in a row.ⁱⁱ

Many physicians are now recommending taking FDgard before a meal, as it enables the supportive effect of FDgard to start as early as possible. By reducing anticipatory anxiety related to meal-triggered indigestion, FDgard, as a PreMeal Companion^®, provides the Shield of Confidence^®. The usual adult dose of FDgard is two capsules, 30 to 60 minutes before meals, up to two times a day, not to exceed six capsules per day.  While FDgard does not require a prescription, it should be used under medical supervision, since it is a medical food.  

Nonprescription FDgard is available to patients in the digestive aisle in major retailers nationwide, including CVS/pharmacy, Rite Aid, Walgreens, select Walmart locations, and many grocery stores. It can also be purchased online at Amazon.

About the American College of Gastroenterology
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 ACG seeks to be the preeminent champion for prevention, diagnosis, and treatment of digestive disorders by facilitating the highest quality, compassionate, and evidence-based patient care. www.gi.org. ACG can be followed on Twitter @AmCollegeGastro.

About IM HealthScience^®
IM HealthScience^® (IMH^®) is the innovator of the medical foods IBgard^® and FDgard^® for the dietary management of Irritable Bowel Syndrome (IBS) and Functional Dyspepsia (FD or recurring indigestion), respectively. IBS may often migrate to FD, and vice versa, or both conditions may overlap in the same patient.²⁴ IMH rounds out its line of digestive products with Fiber Choice^®, a well-known, natural chewable prebiotic fiber supplement that helps support daily regularity. IMH, along with its sister company, Physician's Seal^® (PS), also co-markets the innovative sleep product, REMfresh^®. REMfresh is the first and only continuous release and absorption melatonin (CRA-melatonin™) supplement for sleep. It is a 99 percent ultrapure melatonin that mimics the way the body naturally releases and maintains melatonin over a 7-hour period.

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. Both IMH and PS are dedicated to developing products to address overall health and wellness in digestive health and sleep. The IM HealthScience and Physician's Seal advantage comes from developing products based on patented, targeted-delivery technologies, including IPP^® (Ion-Powered Pump^®) and SST^® (Site-Specific Targeting^®) technologies. 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.

Visit IM HealthScience at booth #1438 to learn more about FDgard^®.

Data Presented at ACG 2019 Poster Session on October 29, 2019, from 1 PM to 2:15 PM

• (Poster # 2163) 24-Month Post-Marketing Safety Surveillance Data of Caraway Oil and L-Menthol With Site-Specific Targeting (COLM-SST^®): A Novel Formulation for FD
  • Brian Lacy, PhD, MD, FACG, Michael Epstein, MD, FACG, Syed Shah, PhD, Patrick Corsino, PhD.

i.  With no known organic cause.
ii.  IQVIA; ProVoice survey; June 2019. Among all herbal products for functional dyspepsia.                                     

References

1. Data on File at IM HealthScience. FDSU12, Functional Dyspepsia Safety Update at 12 Months for Medical Food FDgard.; 2017.
2. Chey WD, Lacy BE, Cash BD, Epstein M, Corsino PE, Shah SM. A Novel, Duodenal-Release Formulation of a Combination of Caraway Oil and L-Menthol for the Treatment of Functional Dyspepsia: A Randomized Controlled Trial. Clin Transl Gastroenterol. 2019;10(4).
3. Lacy BE, Chey WD, Cash BD, Epstein M, Shah S. A Caraway Oil/L-Menthol Combination Improves Functional Dyspepsia (FD) Symptoms within the First 24 Hours: Results of a Randomized Controlled Trial, Which Allowed Usual FD Treatments. In: Digestive Disease Week. Chicago, IL; 2017.
4. Chey WD, Lacy BE, Cash BD, Epstein M, Shah S. 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. In: Digestive Disease Week - Chicago IL. ; 2017.
5. Chey WD, Lacy BE, Cash BD, Epstein M, Shah S. 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 (FD). In: Digestive Disease Week - Chicago IL. ; 2017.
6. FDACT (Functional Dyspepsia Adherence and Compliance Trial) - Rapid relief of functional dyspepsia symptoms with a novel formulation of caraway oil and L-menthol: outcomes from a self-reported patient outcomes study - Chey, W. In: American College of Gastroenterology Annual Conference - Orlando, FL. ; 2017.
7. Talley NJ. Functional Dyspepsia : Advances in Diagnosis and Therapy. Gut Liver. 2017;11(3):349-357.
8. Voiosu TA, Giurcan R, Voiosu AM, Voiosu MR. Functional dyspepsia today. Maedica - a J Clin Med. 2013;8(1):68-74. doi:10.1097/00001574-200411000-00007
9. Mahadeva S, Goh KL. Epidemiology of functional dyspepsia: A global perspective. World J Gastroenterol. 2006;12(17):2661-2666. doi:10.3748/wjg.v12.i17.2661
10. Juergens U, Stober M, Vetter H. The anti-inflammatory activity of L-menthol compared to mint oil in human monocytes in vitro: a novel perspective for its therapeutic use in inflammatory diseases. Eur J Med Res. 1998;3(12):539-545.
11. Keshavarz A, Minaiyan M, Ghannadi A, Mahzouni P. Effects of carum carvi L. (Caraway) extract and essential oil on TNBS-induced colitis in rats. Res Pharm Sci. 2013;8(1):1-8.
12. Adam B, Liebregts T, Best J, et al. A combination of peppermint oil and caraway oil attenuates the post-inflammatory visceral hyperalgesia in a rat model. Scand J Gastroenterol. 2006;41(2):155-160. doi:10.1080/00365520500206442
13. Baananou S, Bagdonaite E, Marongiu B, et al. Extraction of the volatile oil from Carum carvi of Tunisia and Lithuania by supercritical carbon dioxide: chemical composition and antiulcerogenic activity. Nat Prod Res. 2013;27(22):2132-2136. doi:10.1080/14786419.2013.771350
14. Rozza AL, Meira De Faria F, Souza Brito AR, Udia C, Pellizzon H. The Gastroprotective Effect of Menthol: Involvement of Anti-Apoptotic, Antioxidant and Anti-Inflammatory Activities. PLoS One. 2014;9(1):1-6. doi:10.1371/journal.pone.0086686
15. Lacy BE, Weiser KT, Kennedy AT, Crowell MD, Talley NJ. Functional dyspepsia: the economic impact to patients. Aliment Pharmacol Ther. 2013;38(May):170-177. doi:10.1111/apt.12355
16. Amato A, Liotta R, Mulè F. Effects of menthol on circular smooth muscle of human colon: Analysis of the mechanism of action. Eur J Pharmacol. 2014. doi:10.1016/j.ejphar.2014.07.018
17. Liu B, Fan L, Balakrishna S, Sui A, Moris JB, Jordt S-E. TRPM8 is the Principal Mediator of Menthol-induced Analgesia of Acute and Inflammatory Pain. Pain. 2013;154(10):2169-2177. doi:10.1016/j.pain.2013.06.043.TRPM8
18. Alhaider A, Al-Mofleh I, Mossa J, Al-Sohaibani M, Rafatullah S, Qureshi S. Effect of Carum carvi on experimentally induced gastric mucosal damage in Wistar albino rats. Int J Pharmacol. 2006;2(3):309-315.
19. Micklefield G, Jung O, Greving I, May B. Effects of intraduodenal application of peppermint oil (WS 1340) and caraway oil (WS 1520) on gastroduodenal motility in healthy volunteers. Phyther Res. 2003;17:135-140. doi:10.1002/ptr.1089
20. Goerg KJ, Spilker T. Effect of peppermint oil and caraway oil on gastrointestinal motility in healthy volunteers: A pharmacodynamic study using simultaneous determination of gastric and gall-bladder emptying and orocaecal transit time. Aliment Pharmacol Ther. 2003. doi:10.1046/j.1365-2036.2003.01421.x
21. May B, Köhler S, Schneider B. Efficacy and tolerability of a fixed combination of peppermint oil and caraway oil in patients suffering from functional dyspepsia. Aliment Pharmacol Ther. 2000;14:1671-1677. doi:10.1046/j.1365-2036.2000.00873.x
22. Rich G, Shah A, Koloski N, et al. A randomized placebo-controlled trial on the effects of Menthacarin, a proprietary peppermint- and caraway-oil-preparation, on symptoms and quality of life in patients with functional dyspepsia. Neurogastroenterol Motil. 2017;29(May):e13132. doi:10.1111/nmo.13132
23. Madisch A, Heydenreich CJ, Wieland V, Hufnagel R, Hotz J. Treatment of functional dyspepsia with a fixed peppermint oil and caraway oil combination preparation as compared to cisapride. A multicenter, reference-controlled double-blind equivalence study. Arzneimittelforschung. 1999;49(11):925-932. doi:10.1055/s-0031-1300528
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This information is for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professional. This information should not be used for diagnosing a health problem or disease. While medical foods do not require prior approval by the FDA for marketing, they must comply with regulations. It should not be assumed that medical foods are alternatives for FDA-approved drugs. Only doctors can definitively diagnose functional dyspepsia. Use under medical supervision. The company will strive to keep information current and consistent but may not be able to do so at any specific time. Generally, the most current information can be found on www.fdgard.com. Individual results may vary.

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