The US Food and Drug Administration (FDA) has granted approval for Actavis’s Viberzi (eluxadoline) as a twice-daily and oral treatment for adults suffering from irritable bowel syndrome with diarrhoea (IBS-D).
IBS-D is a functional bowel disorder, which is characterised by chronic abdominal pain and frequent diarrhoea.
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Viberzi is an orally active compound for treating IBS-D in men and women. With mixed opioid receptor activity, Viberzi is a mu receptor agonist, delta receptor antagonist and kappa receptor agonist.
Actavis global brands R&D executive vice-president David Nicholson said: "The FDA’s approval of Viberzi is the first step to providing physicians with a new, evidence-based, treatment option for their adult patients with IBS-D.
"At Actavis, we are dedicated to providing new treatment options, and the development of new agents that help address the most bothersome symptoms of IBS-D."
Viberzi’s efficacy was proved in two Phase III clinical studies, which demonstrated significant superiority over placebo on the composite endpoint of simultaneous improvement in both abdominal pain and diarrhoea at both 75mg and 100mg twice-daily doses.
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By GlobalDataThe primary efficacy responder endpoint was assessed over the duration of double-blind and placebo-controlled treatment.
According to the company, response rates were compared based on patients who met the daily composite response criteria for at least 50% of the days from weeks one to 12 (FDA endpoint) and weeks one to 26 (European Medicines Agency endpoint).
Image: Actavis Biologics Ltd, Estuary Banks, Liverpool. Photo: courtesy of Rept0n1x.
