The US Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhoea and abdominal pain in men and women with diarrhoea predominant irritable bowel syndrome (IBS-D). Actavis' NDA for eluxadoline has been granted priority review status by the FDA.
"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 Paul Covington, MD, senior vice president, clinical operations & development at 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."
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 diarrhoea at both 75mg and 100mg doses.
Eluxadoline was well-tolerated and the adverse events (reported in greater than 5 per cent of eluxadoline-treated patients and at an incidence greater than placebo) consisted of constipation (7.4 per cent (75 mg) and 8.6 per cent (100 mg) vs 2.5 per cent placebo), nausea (8.1 per cent (75mg) and 7.5 per cent (100mg) vs 5.1 per cent placebo) and abdominal pain (4.1 per cent (75mg) and 5.0 per cent (100mg) vs 2.7 per cent placebo). The studies consisted of 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.
Eluxadoline is a novel, orally active investigational compound being developed for the treatment of diarrhoea and abdominal pain in men and women with diarrhoea 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.
IBS-D is a functional bowel disorder characterised by chronic abdominal pain and frequent diarrhoea, which affects approximately 15 million patients in the USA 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 productivity, along with decreased quality of life.