IM HealthScience post-marketing surveillance study affirms FDgard safety profile

BOCA RATON, Fla. — IM HealthScience on Monday announced favorable results from its Functional Dyspepsia Safety Update at 6 months (FDSU-6), a real-world, post-marketing surveillance study reporting on the safety and tolerability profile of FDgard among the more than 182,000 patients who used the product. The results found no serious adverse events.



Additionally, the rates and patterns of non-serious adverse events were low (0.02%) and generally consistent with those normal adverse events commonly associated with an FD population.



FDgard is a non-prescription medical food specially formulated for the dietary management of Functional Dyspepsia. "Functional dyspepsia can have a significant impact on one's quality of life," stated Michael Epstein,chief medical advisor for IM HealthScience. "The findings from FDSU-6 reaffirm the safety and tolerability profile of FDgard in real-world settings."



FDgard capsules contain caraway oil and l-Menthol, the primary component in peppermint oil, for the dietary management of FD. FD is often characterized as non-heartburn indigestion with no known organic cause. Currently, there are few options for doctors and their patients to manage FD.  



Approximately 30% of adults suffer from dyspepsia, and about half are estimated to have FD, or non-ulcer dyspepsia. 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, epigastric burning, postprandial fullness, early satiation, bloating in the upper abdomen, nausea and belching.