Updated on 4 September 2014
Mr Paul Covington, MD, senior vice president, clinical operations & development, Furiex Pharmaceuticals
Singapore: "The NDA filing of Eluxadoline marks an important step forward for this potential first-in-class treatment, which demonstrates our commitment to helping patients suffering from this debilitating condition," said Mr Paul Covington, MD, senior vice president, clinical operations and development, Furiex Pharmaceuticals, a subsidiary of Actavis.
"We are pleased that the FDA has granted Eluxadoline a priority review, setting the stage for us to bring this potential new treatment option to patients promptly," he added.
The NDA submission for Eluxadoline is based on the results of two Phase III clinical studies that met their primary endpoints.
The 12-week efficacy portion of the studies demonstrated significant superiority over placebo in the composite endpoint of the simultaneous improvement in both pain and diarrhea at both 75mg and 100mg doses.
Eluxadoline was well-tolerated and the adverse events (reported in greater than 5 percent of Eluxadoline-treated patients and at an incidence greater than placebo) consisted of constipation [7.4 percent (75 mg) and 8.6 percent (100 mg) vs 2.5 percent placebo], nausea [8.1 percent (75mg) and 7.5 percent (100mg) vs 5.1 percent placebo] and abdominal pain [4.1 percent (75mg) and 5.0 percent (100mg) vs 2.7 percent placebo]. The studies consisted of approximately 2,500 patients.