Actavis and Valeant see FDA approval for IBS drugs
pharmafile | May 28, 2015 | News story | Sales and Marketing | Actavis, FDA, IBS, Valeant, brett wells
Both Actavis and Valeant have been shown the green light for their respective irritable bowel syndrome (IBS) treatments from the The Food and Drug Administration.
Actavis’ Viberzi (eluxadoline) is now approved to manage IBS with diarrhoea (IBS-D) in adults, and the regulator has recommended that the Irish firm’s drug is classified as a controlled substance.
Now submitted to the US Drug Enforcement Administration (DEA), following its final scheduling designation the launch of Viberzi is expected to be in the first quarter of 2016.
Its efficacy was established in two Phase III clinical studies, demonstrating significant superiority over placebo on the composite endpoint of simultaneous improvement in both abdominal pain and diarrhoea.
“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,” says executive VP of Actavis global brands R&D David Nicholson.
The US agency has also approved Canadian-based Valeant’s antibiotic Xifaxan (rifaximin), which the firm secured through its recent $11 billion purchase of Salix Pharmaceuticals.
Both drugs are designed to treat IBS-D, a condition that affects around 28 million people in the US and Europe and can cause abdominal pain, bloating and diarrhoea.
The FDA approval of Xifaxan is based on data from three Phase III studies in over 3,000 patients, which demonstrated the efficacy and safety of repeat treatment following completion of a two-week course on the drug.
“We are thrilled to offer patients this new option to manage their IBS-D symptoms,” says Bill Forbes, PharmD, president, medical, R&D and chief development officer of Salix.
“The FDA approval in IBS-D extends the reach of Xifaxan 550 mg beyond hepatic encephalopathy to a population greatly in need of a different treatment approach.”
Reuters analysts expect Viberzi to generate US sales of around $450 million within five years, and for Xifaxan sales in IBS-D to top $1 billion.
Brett Wells
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