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news.The US Food and Drug Administration (FDA) has granted approval for Irish OTC firm Actavis' Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D), a multifactorial disorder.
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The company said that Viberzi has mixed opioid receptor activity, it is a mu receptor agonist, a delta receptor antagonist and a kappa receptor agonist.
IBS-D is characterized by recurrent abdominal pain or discomfort and altered bowel function that affects as many as 15 million adults in the US.
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.
"We are very pleased to be working with the FDA to advance this IBS-D treatment and we eagerly await DEA scheduling determination later this year."
The FDA has recommended that Viberzi be classified as a controlled substance and the recommendation has been submitted to the US Drug Enforcement Administration (DEA).
The company said that once Viberzi receives final scheduling designation, the updated label will be available.
Pending final scheduling designation, the company intends to launch the product in the first quarter of 2016.
Efficacy of Viberzi was established in two Phase III clinical trials, showing significant superiority over placebo on the composite endpoint of simultaneous improvement in both abdominal pain and diarrhea at both 75mg and 100mg twice daily doses.