VIBERZI (eluxadoline) has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist, and a kappa receptor agonist.
VIBERZI™ (eluxadoline) was approved by the Food and Drug Administration (FDA) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D).
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 diarrhea 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).
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. A total of 2,426 subjects were enrolled across the two studies.
USFDA approval details
|FDA Application No.||(NDA) 206940|
|Company||FURIEX PHARMA INC|
|Original Approval or Tentative Approval Date||May 27, 2015|
|Chemical Type||1 New molecular entity (NME)|
FDA approval documents showing Furiex Pharma INC as innovator company, why so?
Actavis acquired Furiex Pharmaceuticals in July, 2014.
The strategic acquisition of Furiex strengthens Actavis’ focus on gastroenterology (GI) where we are an industry leader, positioning us for continued long-term growth in IBS treatment. Furiex’s lead development product eluxadoline is a natural extension Actavis GI business, complementing to Actavis’s Linzess® and Asacol® and Delzicol®.
Eluxadoline approval could represent a significant advance in the treatment of IBS-D, and would give Actavis one of the broadest product offerings for the $38 billion GI disease market. This product, if successful, would make Actavis even more relevant to gastroenterologists and primary care physicians in meeting significant patient needs.