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Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline
Date:9/2/2014

f approximately 2,500 patients. 

Pursuant to pre-NDA discussions with FDA, Actavis is planning to submit an amendment to the NDA with additional data from a study that was ongoing at the time of submission. As a result, it is expected that this will extend the Prescription Drug User Fee Act (PDUFA) date by three months.  The Company expects the PDUFA date to be in 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.

About Eluxadoline Eluxadoline is a novel, orally active investigational compound being developed for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant irritable bowel syndrome (IBS-D).  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.

About IBS-DIBS-D is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea, which affects approximately 15 million patients in the U.S.  Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gastrointestinal track and nervous system interact.

IBS-D can be debilitating and there are limited therapeutic options for managing the chronic symptoms. IBS-D is associated with economic burden in direct medical costs and indirect social costs such as absenteeism and lost productivit
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