Results from two phase III trials have shown eluxadoline to be an effective therapeutic for reducing the symptoms of IBS with diarrhoea (IBS-D) in men and women.

“Currently, limited treatments for patients suffering from IBS-D exist,” points out author Anthony Lembo. Eluxadoline is the third drug approved by the FDA for treating IBS-D and functions as a peripherally acting μ-opioid and κ-opioid receptor agonist and δ-opioid receptor antagonist. Via the enteric nervous system, these receptors regulate gastrointestinal motility, secretion and visceral sensation. Potentially as a result of its mixed opioid receptor effects, previous nonclinical studies suggested that eluxadoline can reduce constipation, often a serious adverse effect with other IBS-D drugs, and enhance analgesia.

The trials involved 2,427 patients, randomly assigned to receive either eluxadoline or a placebo over a period of up to 52 weeks. The investigators used simultaneous reductions in daily abdominal pain and improvements in stool consistency for at least 50% of the days within the treatment period as the primary end point. The results showed that a greater percentage of the patients receiving eluxadoline met these primary end points than those receiving the placebo, demonstrating that the drug is effective in relieving both abdominal pain and diarrhoea. The most common adverse effects were nausea and constipation, but <2% of patients withdrew from the trial because of constipation. Pancreatitis occurred in five individuals receiving eluxadoline, three of whom also had a history of excessive alcohol consumption.

Based on these results, “eluxadoline provides physicians with another tool to help treat their patients,” concludes Lembo who cautions that the drug is not recommended for individuals who drink >3 alcoholic drinks per day. Additional secondary and exploratory analyses are planned by the investigators, as well as identifying subpopulations of patients that might best benefit from treatment with eluxadoline.