IM HealthScience presents clinical evidence of FDgard efficacy

CHICAGO — IM HealthScience submitted clinical data highlighting an advance in the management of functional dyspepsia with FDgard demonstrated unprecedented symptom reduction and rapid relief of FD symptoms in patients in only 24 hours.



"These study results are uniquely important and represent an advance in the management of functional dyspepsia," stated Michael Epstein, chief medical advisor for IM HealthScience. "We believe that FDgard possesses anti-inflammatory, analgesic and gastro-protective properties, which likely are responsible for the rapid relief and steady improvement of FD symptoms in patients even when used as an add-on therapy to commonly used, off-label medications to treat FD, as demonstrated in the FDREST study," he said. "In particular, many FD symptoms flare within 2 hours after a meal, so the fast action seen in this FDgard study is an important advance."



The data was presented during Digestive Disease Week, a gastroenterology meeting.  



FDgard showed effective symptom reduction and rapid relief of FD symptoms in a sub-group of FD patients with epigastric pain syndrome and postprandial distress syndrome. Additionally, the study findings showed that FDgard as an add-on product improved FD symptoms in patients already using commonly used, off-label medications prescribed for FD, such as proton pump inhibitors and histamine receptor 2 antagonists, anticonvulsants, antibiotics, antihistamines, antidepressants and antacids as rescue medications.



FD is often characterized as persistent or recurring indigestion with no known organic cause and is an area of high unmet medical need. Currently, off-label medications are used to treat FD as there is no FDA-approved pharmaceutical product for the condition, IM HealthScience stated.



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 PDS symptoms and near statistical significance in EPS symptoms at 24 hours. In spite of the polypharmacy and use of rescue medications after 48 hours of first dose, FDgard helped further improve symptoms at 4 weeks.



At the 24 hour mark, there was a 14% improvement of EPS symptoms from baseline and a 9.9% reduction of PDS symptoms from baseline.



At 4 weeks, approximately 75% of the EPS and PDS patients in the FDgard arm reported substantial symptom improvement vs. approximately half in the control arm.



An estimated 62% of FD patients suffer from EPS, while an estimated 73% of FD patients suffer from PDS. The overlap of EPS and PDS, which are those FD patients who suffer from both syndromes, is estimated to be 35%.