FDA Approves Two New Drugs for Irritable Bowel Syndrome
The Food and Drug Administration (FDA) on Wednesday approved new drugs from Actavis Plc and Valeant Pharmaceuticals International Inc for irritable bowel syndrome.
US health regulators gave approval for the drug named eluxadoline, which will be sold under the brand name of Viberzi, which Actavis obtained with its $1.1 billion acquisition last year of Furiex Pharmaceuticals.
It has been said that the agency also approved Valeant's Xifaxan, also known as rifaximin, which the company acquired with its $11 billion purchase of Salix Pharmaceuticals Ltd. made this year.
Both the drugs have been specifically designed to treat diarrhea-predominant irritable bowel syndrome (IBS-D). This is a condition that affects about 28 million people in the United States and Europe and can cause abdominal pain, bloating and diarrhea.
As per analysts' expectations, Viberzi would generate US sales of about $450 million by 2020 according to Thomson Reuters data. They also expect that Xifaxan sales for IBS-D to top $1 billion.
Manufacturers of the drug said that both the drugs work in different way. Xifaxan is an antibiotic that was approved in 2004 to treat traveler's diarrhea. Later it got approval in 2010 to treat the risk of hepatic encephalopathy, or brain abnormalities associated with liver disorders.
On the other hand, Viberzi is known as a combination mu opioid receptor agonist and delta opioid receptor antagonist. The drug has been designed to treat IBS-D while reducing the risk of constipation that can occur with other mu opioid receptor agonists, such as the anti-diarrhea drug Imodium.
Dr. Julie Beitz, director of the FDA office in charge of the review, said, "For some people, IBS can be quite disabling, and no one medication works for all patients suffering from this gastrointestinal disorder".
FDA said the drugs also have some side effects, and the most common side-effects of Xifaxan include nausea and raised liver enzymes. On the other hand, the most serious side-effect of Viberzi is the risk of inflammation of the pancreas known as pancreatitis.
