The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion for the medicinal product Truberzi, intended for the treatment of adults with irritable bowel syndrome with diarrhoea ( IBS-D ).
Truberzi is available as 75 and 100 mg film-coated tablets. The active substance of Truberzi is Eluxadoline, a locally acting, mixed mu opioid receptor ( muOR ) agonist and delta opioid receptor ( deltaOR ) antagonist.
Eluxadoline is also an agonist at the kappa opioid receptor ( kappaOR ) normalising gastrointestinal transit and defecation.
It has been shown to reverse hyperalgesic responses in an animal model of acute colitis-induced visceral pain.
The benefits with Truberzi in patients with IBS-D are its ability to increase days with no diarrhoea and to improve pain.
The rate of patients with no diarrhoea and reduced pain for at least 50% of the days over a 26 week period was about 11.5 percentage points higher with Truberzi 100 mg than with placebo, whereas the difference was about 7 percentage points with Truberzi 75 mg.
The most common side effects are constipation ( 7% and 8% of patients receiving 75 mg and 100 mg respectively ), nausea ( 8% versus 7% ) and abdominal pain/abdominal distension ( 7% versus 7% ).
Serious adverse reactions include pancreatitis ( 0.2% and 0.3% of patients receiving 75 mg and 100 mg respectively ) and sphincter of Oddi spasm ( 0.2% versus 0.8% ).
The full indication is: Truberzi is indicated in adults for the treatment of irritable bowel syndrome with diarrhoea. ( Xagena )
Source: EMA, 2016