New treatments are emerging daily for countless conditions and diseases—pills and injectables being the foremost of these. But there is also another category of treatments that has been causing a stir in the healthcare market: medical food.
According to the FDA, medical food is “intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” Other definitions of medical food explain that this specially formulated treatment is intended “for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone.”
“A medical food is a product regulated by law. It is often placed on the spectrum between a food and a drug,” said Dr. Michael Epstein, MD, FACG, AGAF, Chief Medical Advisor of IM HealthScience®, Founder and Principle Physician of Digestive Disorders Associates, and President of the Maryland Diagnostic & Therapeutic Endo Center. “A medical food is used in the dietary management of a disease or condition. It is required to be used under medical supervision. It is allowed to be sold as a nonprescription product.”
Since its emergence on the market, one medical food has gained increasing popularity: IBgard®. IBgard was created for the dietary management of irritable bowel syndrome (IBS) and contains ultra-purified peppermint oil.
The company that created IBgard, IM HealthScience, has recently revealed one of its newest products—FDgard™.
Specially formulated for the dietary management of functional dyspepsia (FD), FDgard is a new, non-prescription medical food that combines caraway oil and peppermint oil (primary component: l-Menthol). These capsules deliver “individually triple-coated targeted release microspheres of caraway oil and l-Menthol quickly and reliably to the upper belly,” according the FDgard website.
Here are a few fast facts about FD:
In the past, medications such as Prilosec and Nexium have been used to treat FD as well as for checking bacterial infection in the stomach. Antidepressants and dietary therapies have also been tried, but with limited success.
The Discovery of FDgard
“Caraway seeds have a long history of alleviating symptoms of dyspepsia in Asia, Europe, and Africa. The two major terpenes in CO have unique properties. D-Limonene helps neutralize gastric acid and improve gallbladder function and d-Carvone reduces nerve excitability which provides pro-motility and analgesic action,” said Epstein.
“The combination of caraway oil and peppermint oil has been clinically studied in FD and results show that the combination effectively manages FD symptoms,” he continued. “IM HealthScience discovered that these essential oils could be turned into solid state microspheres.”
Enhancing the effectiveness and safety, the delivery of caraway oil and l-Menthol as microspheres to the duodenum builds upon previous research. The U.S. has granted four patents for this unique technology.
FDgard™ utilizes SST® (Site Specific Targeting) technology to deliver individually triple-coated, targeted-release, solid-state microspheres of caraway oil and l-Menthol quickly and reliably where they are needed most in functional dyspepsia (FD) — the upper belly.
How FDgard Works
“FDgard is similar to IBgard but with a more rapid release in the upper small intestine (duodenum), and includes a fiber matrix to trap the PO and CO in solid states,” said Epstein. “The inner seal coat keeps the terpenes from leaching out of the microspheres and the middle coat is triggered to release at a pH just past the stomach. Finally, there is a non-muco adherent coat to allow smooth passage of the microspheres through the pylorus—the sphincter muscle between the stomach and duodenum.”
Since FD is a gastroduodenal disorder, previous studies have demonstrated that the duodenum is the best site for the ingredients in FDgard to work in FD, Epstein states.
Despite some similarities to IBgard, such as the ingredient of peppermint oil, FDgard has some key differences. According to Epstein, these differences include the following:
- FDgard contains caraway oil and l-Menthol, the primary component in PO.
- IBgard releases its microspheres in the small intenstine, whereas the FDgard capsule releases in the duodenum, just past the stomach.
Study Findings
“The May Pivotal Study Aliment Pharmacol Ther 2000: 14: 1671-1667, a multicenter placebo controlled study, demonstrated reduction in pain intensity, sensation of pressure, heaviness and fullness, and global improvement of symptoms,” said Epstein.
Approximately 96 patients were enrolled in this study. Based on patient-reported outcome, the active group had a rating of “much improved,” as compared with placebo, which reported minimal to no improvement.
According to Epstein, four other randomized placebo controlled studies of the caraway oil/peppermint oil combination have demonstrated similar results. A total of approximately 700 patients have been studied through these clinical trials.
Currently, there is no FDA-approved treatment for the management of FD.
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Filed Under: Drug Discovery, Gastroenterology
