The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval for eluxadoline (Truberzi, Aptalis Pharma SAS) for the treatment of adults with irritable bowel syndrome (IBS) with diarrhea, according to an EMA news release.
Eluxadoline is a mixed mu-opioid receptor agonist and delta-opioid receptor antagonist that acts locally to normalize gastrointestinal transit and defecation. It also has agonist activity at the kappa-opioid receptor and reversed hyperalgesic responses in an animal model of acute visceral pain caused by colitis.
Eluxadoline will be available as film-coated tablets containing 75 mg and 100 mg of the medication, and it is proposed that it be available by prescription.
The US Food and Drug Administration approved eluxadoline (Viberzi, Actavis) on May 27, 2015, for the same indication.
The committee's decision follows a review of data published in the New England Journal of Medicine showing that eluxadoline increased diarrhea-free days and improved pain. During a 26-week period, the rate of patients without diarrhea and with reduced pain for at least 50% of the days was approximately 11.5 percentage points higher in those who took eluxadoline 100 mg than in those who took placebo, and about 7 percentage points higher in those who took eluxadoline 75 mg than in those who took placebo.
The most frequently reported side effects were constipation (7% and 8% of those receiving 75 mg and 100 mg, respectively), nausea (8% and 7% of those receiving 75 mg and 100 mg, respectively), and abdominal pain or abdominal distension (7% and 7% of those receiving 75 mg and 100 mg, respectively).
Serious adverse reactions reported included pancreatitis (0.2% and 0.3% of those in the 75-mg and 100-mg groups) and sphincter of Oddi spasm (0.2% of those in the 75-mg and 0.8% of patients in the 100-mg groups, respectively).
The summary of product characteristics will contain detailed recommendations for the use of this medication and will be published in the European public assessment report. The report will be available in all official European Union languages after the European Commission grants marketing authorization.
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Cite this: CHMP Backs Eluxadoline (Truberzi) for IBS With Diarrhea - Medscape - Jul 22, 2016.
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