The Food and Drug Administration (FDA) has approved Actavis' Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhoea (IBS-D).
IBS-D is a multifactorial disorder marked by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adult Americans, impacting about twice as many women as men. There are few treatment options available for IBS-D, particularly options that relieve both the diarrhea and abdominal pain associated with IBS-D.
The FDA has recommended that Viberzi be classified as a controlled substance. This recommendation has been submitted to the U.S. Drug Enforcement Administration (DEA). Viberzi is an orally active compound indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in men and women. Viberzi (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.
Efficacy was established in two phase III clinical studies, demonstrating significant superiority over placebo on the composite endpoint of simultaneous improvement in both abdominal pain and diarrhoea at both 75 mg and 100 mg twice daily doses. The primary efficacy responder endpoint was evaluated over the duration of double-blind, placebo-controlled treatment. Response rates were compared based on patients who met the daily composite response criteria (improvement in both abdominal pain and stool consistency on the same day) for at least 50% of the days from weeks 1 to 12 (FDA endpoint) and weeks 1 to 26 (European Medicines Agency endpoint). A total of 2,426 subjects were enrolled across the two studies. The most common adverse events in the two phase III clinical trials were constipation (7% and 8% for eluxadoline 75 mg and 100 mg; 2% for placebo) and nausea (8% and 7% for eluxadoline 75 mg and 100 mg; 5% for placebo). Rates of severe constipation were less than 1% in patients receiving 75 mg and 100 mg eluxadoline. Rates of discontinuation due to constipation were low for both eluxadoline and placebo (=2%) and similar rates of constipation occurred between the active and placebo arms beyond 3 months of treatment. Irritable bowel syndrome with diarrhoea (IBS-D) is a functional bowel disorder characterized by chronic abdominal pain and frequent diarrhoea, which affects approximately 15 million patients in the US. Although the exact cause of IBS-D is not known, symptoms are thought to result from a disturbance in the way the gastrointestinal tract 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.
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