The NDA is based on the results of two Phase III clinical trials that met their primary endpoints.
The 12-week efficacy portion of the trials showed significant superiority over placebo in the composite endpoint of the simultaneous improvement in both pain and diarrhea at both 75mg and 100mg doses.
Actavis subsidiary Furiex Pharmaceuticals senior vice president of Clinical Operations and Development Paul Covington said the NDA filing of eluxadoline marks an important step forward for this potential first-in-class treatment, which shows the company’s commitment to helping patients suffering from this debilitating condition.
"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," Covington said.
Around 2,500 patients were involved in these trials, which showed that eluxadoline was well-tolerated, and the adverse events included constipation, nausea and abdominal pain.
The company is focused in developing and manufacturing generic, brand, branded generic, legacy brands and over-the-counter (OTC) pharmaceutical products and has commercial operations in about 60 countries.