36-Month Post-Marketing Surveillance Report For FDgard®, Now Available For Review At The American College Of Gastroenterology (ACG) E-Poster Website
BOCA RATON, Fla., Oct. 26, 2020 /PRNewswire/ -- IM HealthScience® (IMH) today announced that the Functional Dyspepsia Safety Update at 36 months (FDSU36) poster is now available for review at the American College of Gastroenterology (ACG) e-paper and e-poster website. The poster summarizes results from adverse reaction reports voluntarily submitted by users of FDgard®.
The peer-reviewed and published poster is titled, "3 YEARS AND 1 MILLION PATIENTS: SAFETY DATA ON CARAWAY OIL AND L-MENTHOL WITH SITE SPECIFIC TARGETING (COLM-SST) FOR FUNCTIONAL DYSPEPSIA."
FDSU361 involves a post-marketing analysis of the adverse events voluntarily reported by users in a real-world surveillance program reporting on the safety and tolerability profile of FDgard®. It is estimated that approximately 1.0 million individual patients used the product during the three-year safety surveillance period of July 2016 to July 2019. During that time, no serious adverse events were reported. Additionally, the rate of reported non-serious adverse events was low (0.019%), with 205 events received from 179 patients. No pattern of adverse reactions associated with drug interactions was observed.
"We are gratified that this important post-marketing study has been peer-reviewed, accepted, and made available for review online at ACG," said Michael Epstein, M.D., FACG, AGAF, a leading gastroenterologist and Chief Medical Advisor for IM HealthScience®. "Health care professionals have few effective or safe options in the management of meal triggered indigestion or FD, and it is important for health care professionals and patients to be aware that the survey did not identify any serious adverse events and that only non-serious adverse events were reported for FDgard®."
About FDSU36 Study
All boxes of FDgard® contain a call-in number for reporting adverse events (AE's). An independent call center with pharmacovigilance trained personnel, in accordance with the U.S. Federal and Drug Administration (FDA) and global regulatory guidelines on properly reporting AE's, was retained to receive and record customer AE's. Data has been collected and processed from July 2016 to July 2019.
The results include the following1:
- An estimated one million individual patients/consumers 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 205 events received (from 179 patients), for a total estimated rate of 0.019%.
- The most commonly reported non-serious adverse events were abdominal pain/discomfort/distension (35: 0.0032%) and dyspepsia (22: 0.0020%), which is consistent with the pattern of commonly reported symptoms of FD.
Commenting on the findings in the study, Brian Lacy, M.D., Ph.D., FACG, a leading gastroenterologist at the Mayo Clinic and the lead author of the study said, "The findings from 36 months of monitoring in-market, real-world use of FDgard® reaffirm the safety and tolerability profile of FDgard®."
About FDgard®
FDgard® is a medical food designed to address the unmet medical need for products to help manage meal-triggered indigestionⴕ (or FD: Functional Dyspepsia§). 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 solid-state microspheres that are then triple-coated. With the patented Site-Specific Targeting® (SST®) technology pioneered by IM HealthScience, FDgard® capsules are designed to contain these solid-state, triple-coated microspheres and to have them move intact rapidly through the stomach and then to release the caraway oil and l-Menthol quickly and reliably where they are needed most in FD, in the duodenum (upper belly)2.
About IM HealthScience®
IM HealthScience® (IMH) is the innovator of IBgard® and FDgard® for the dietary management of Irritable Bowel Syndrome (IBS) and meal triggered indigestion (or FD: Functional Dyspepsia), respectively. In 2017, IMH added Fiber Choice®, a line of prebiotic fibers, to its product line via an acquisition. IMH 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. The IMH advantage comes from developing products based on its patented, targeted-delivery technologies called Site-Specific Targeting® (SST®). On September 1, 2020, IBgard®, FDgard®, Fiber Choice®, and REMfresh® were acquired by Nestlé Health Science. 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.
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.
ⴕ with no known organic cause
§ use under medical supervision
References:
1. |
FDSU36, Functional Dyspepsia Safety Update at 36 months for Medical Food FDgard. |
Peer-reviewed and presented at The American College of Gastroenterology Annual |
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Scientific Meeting, October 2020 |
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2. |
Castillo EJ, Camilleri M, Locke GR, et al. A community-based, controlled study of the |
epidemiology and pathophysiology of dyspepsia. Clin Gastroenterol Hepatol. |
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2004;2(11):985-996. doi:10.1016/S1542-3565(04)00454-9. |
PreMeal Companion® and Shield of Confidence® are registered trademarks of IM HealthScience®.
The information provided here is for educational purposes only and is not meant to be a substitute for the advice of a physician or other healthcare professionals. These statements have not been evaluated by the Food and Drug Administration. The product and information herein should not be used nor is it intended to diagnose, treat, cure, or prevent any diseases or health problems. FDgard® should be used under medical supervision.
FDgard® is protected by U.S. patents No: 8,568,776; 8,911,780; 8,895,086; 9,192,583; 9,220,686; 9,393,279; 9,572,782; and 9,717,696. Additional patents are pending in the U.S. and other jurisdictions. Keep out of reach of children. Store at room temperature. Individual results may vary. Do not use if blister is torn or ripped or if there is any other evidence of tampering. Please read package insert and the website for more information.
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