On 19 September the European Commission granted a marketing authorisation valid throughout the European Union for the active substance eluxadoline (Truberzi). Eluxadoline acts on the digestive system. It is used for the treatment of adults who have irritable bowel syndrome with diarrhoea.
Eluxadoline is an opioid receptor agonist: it attaches to opioid receptors and acts like the body’s natural opioids to calm down waves of contractions along the digestive system. This causes food to remain in the gut for longer, increasing the absorption of fluids and so reducing diarrhoea. Because eluxadoline is not absorbed into the blood and distributed around the body, its effects are largely confined to the gut.
The drug was evaluated in two main studies compared with placebo involving over 2,400 patients with irritable bowel syndrome with diarrhoea. The study takes over 26 weeks of treatment during which patients kept a daily record of their symptoms. Effectiveness was measured as an improvement of over 30% in abdominal pain combined with an absence of very loose stool.
In the first study effectiveness was shown in 29% (125 out of 426) of patients taking eluxadoline 100 mg twice a day compared with 19% (81 out of 427) in patients taking placebo. In the second study symptoms improved in 33% (125 out of 382) of patients taking eluxadoline 100 mg twice a day compared with 20% (77 out of 382) of patients taking placebo.
Constipation, nausea and abdominal pain was the most common side effects, while serious one include pancreatitis and sphincter of Oddi spasm
The Agency’s Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of the drug are modest but there is an unmet need for treatments of irritable bowel syndrome with diarrhoea. Side effects were mainly limited to the digestive system and mostly mild. The Committee therefore decided that Truberzi’s benefits are greater than its risks and recommended that it be approved for use in the EU.