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FDA Accepts NDA Filing for Eluxadoline
The FDA has accepted for filing a new drug application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea-predominant irritable bowel syndrome (IBS-D). The NDA was granted “priority review” status.
The regulatory submission for eluxadoline was based on the results from two phase III clinical trials that met their primary endpoints. The 12-week efficacy portion of these studies demonstrated the superiority of eluxadoline over placebo in the composite endpoint of simultaneous improvement in pain and diarrhea at 75-mg and 100-mg doses.
Eluxadoline was well tolerated. The most common adverse events included constipation (7.4% for 75 mg and 8.6% for 100 mg vs. 2.5% for placebo); nausea (8.1% for 75 mg and 7.5% for 100 mg vs. 5.1% for placebo); and abdominal pain (4.1% for 75 mg and 5.0% for 100 mg vs. 2.7% for placebo). The studies involved approximately 2,500 patients.
Pursuant to pre-NDA discussions with the FDA, the drug’s developer (Actavis Pharmaceuticals) is planning to submit an amendment to the NDA with additional data from a study that was ongoing at the time of submission. It is expected that this will extend the Prescription Drug User Fee Act (PDUFA) date by 3 months. The company expects that the FDA's approval decision will be made in the second quarter of 2015.
Eluxadoline is an orally active investigational compound being developed for the treatment of diarrhea and abdominal pain in men and women with IBS-D. The medication is a combined mu-opioid receptor agonist and delta-opioid receptor antagonist that acts locally in the gastrointestinal (GI) tract, with low systemic absorption and bioavailability. This 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.
IBS-D is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhea. It affects approximately 15 million people in the U.S. Although the precise cause of IBS-D is unknown, its symptoms are thought to result from a disturbance in the way the GI tract and the nervous system interact.
IBS-D can be debilitating, and there are limited therapeutic options for managing its chronic symptoms. IBS-D is associated with an economic burden in direct medical costs and indirect social costs, such as absenteeism and lost productivity, along with a decreased quality of life.
Source: Actavis Pharmaceuticals; September 2, 2014.