FDA Approves NDA For Actavis' Investigational IBS Treatment

By Lori Clapper

The U.S. Food and Drug Administration (FDA) has accepted Actavis' New Drug Application (NDA) filing for its investigational treatment of symptoms like diarrhea and abdominal pain associated with Irritable Bowel Syndrome. Eluxadoline was also granted priority review by the FDA, the company said in an announcement.

"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," Paul Covington, MD, SVP, Clinical Operations and Development at Furiex Pharmaceuticals, a subsidiary of Actavis, said.  "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." 

Actavis based its NDA submission for eluxadoline on results from two Phase III clinical studies that enrolled around 2,500 patients and met their primary endpoints. During the 12-week efficacy portion of the studies, both the 75 mg and 100 mg doses of the drug performed significantly better than the placebo in improving both pain and eliminating diarrhea. The company also found that the participants in the study tolerated the drug well.

Before Actavis can begin pre-NDA discussions with the FDA, it will submit an amendment containing data from a study that was happening concurrently to the submission process. The company expects that this additional data will extend the Prescription Drug User Fee Act (PDUFA) date by three months to Q2 2015.

"There continues to be an unmet need for treatments to manage the chronic symptoms experienced by patients with IBS-D. If approved, eluxadoline could be a promising option for patients who continue to suffer from these symptoms," said Anthony Lembo, MD, Attending Physician, Beth Israel Deaconess Medical Center and Associate Professor of Medicine, Harvard Medical School.

Eluxadoline is a combined mu opioid receptor agonist and delta opioid receptor antagonist which acts locally in the gastrointestinal tract and has low systemic absorption and bioavailability. The dual opioid activity is designed to treat the symptoms of IBS-D while reducing the incidence of constipation that can occur with unopposed mu opioid receptor agonists