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12-Jun-15 10:00 AM  CST  

FDA Approves Two New Drugs to Treat Irritable Bowel Syndrome –Diarrhea 

Irritable Bowel Syndrome or IBS affects an average of 45 million Americans according to statistics provided by the National Institutes of Health. Unfortunately, only about half of those who suffer IBS symptoms have been positively diagnosed with the condition by their physician. IBS affects twice as many women than men and most often those under the age of 45.

 

There are several classifications of IBS. IBS-D or irritable bowel syndrome and diarrhea, chronic diarrhea is the most severe and main symptom of this condition. In IBS-C or irritable bowel syndrome and constipation, constipation is a frequent and uncontrollable symptom. Finally, in mixed IBS the symptoms of irritable bowel syndrome involve both constipation and diarrhea, but the severity of the symptoms often alternate.

 

Until recently, the treatments for IBS have been limited, but that is all poised to change as the Food and Drug Administration (FDA) announced this week that they would approve two new drugs to treat the symptoms associated with IBS. Viberzi (eluxadoline) is a mu-opioid receptor agonist specifically targeted to treat IBS-D. Marketed by the drug company Actavis, Viberzi works by decreasing bowel contractions and therefore decreasing the number of episodes of diarrhea the patient may experience.

 

The second drug approved by the FDA for IBS-D is actually classified as an antibiotic. Xifaxan (rifaximin), manufactured and distributed by Salix Pharmaceuticals specifically works to treat bacterial infection in the intestines. Unlike most antibiotics, Xifaxan passes through the stomach and intestines without being absorbed into the bloodstream. This ability to be absorbed by the stomach and intestines helps to reduce infection and the risk associated with increased bouts of diarrhea seen in patients diagnosed with IBS-D.

 

An added benefit with Viberzi is that it helps to reduce the pain often felt by patients diagnosed with IBS-D. Because Viberzi is a mu-opioid receptor agonist it is considered to be a narcotic, which means the Drug Enforcement Agency (DEA) will need to determine a schedule for the drug. The DEA has yet to make this determination, but one should be made within the coming weeks.

 

The downside to Xifaxan is the cost. This seems to be an issue that is becoming more and more prevalent with new and old drugs on the US market. Most drug manufactures attribute the high price tags to the costs associated with research and marketing. A therapy of Xifaxan can cost as much as$1700.00, an exorbitant price tag by anyone’s standards. Thankfully, Salix Pharmaceuticals does offer an assistance program that may help alleviate some of the associated cost. Anyone interested in price assistance with Xifaxan should go to Salix Pharmaceuticals website at, https://www.xifaxan.com/he/hepatic-encephalopathy-resources/savings-card/.

 

Resources:

 

Dohney, K., (2015), “Meds OK’d for Hard to Treat IBS with Diarrhea”, WebMD, http://www.webmd.com/ibs/news/20150528/ibs-diarrhea-viberzi-xifaxan, retrieved, 4, June 2015

 

Salix Pharmaceuticals (2015), “Xifaxan”, https://www.xifaxan.com/he/hepatic-encephalopathy-resources/savings-card/, retrieved, 4, June 2015

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For additional information on this Article article, please contact:

Kelley Simmons

Source: Sandy Andrews, CPhT, BLS

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