FDA approves 2 new drugs for IBS with diarrhea — 4 key notes

The U.S. FDA has approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments for irritable bowel syndrome with diarrhea in adults.

Here are four key notes:

1. The safety and effectiveness of Viberzi for treatment of IBS-D was established in two double-blind, placebo-controlled clinical trials which included 2,425 patients.

2. While the safety and effectiveness of Xifaxan for treatment of IBS-D was established in three double-blind, placebo-controlled trials.

3. Viberzi is manufactured by Patheon Pharmaceuticals and is distributed by Forest Pharmaceuticals. Xifaxan is marketed by Salix Pharmaceuticals.

4. The most common side effects in patients treated with Viberzi were constipation, nausea and abdominal pain. And common side effects in patients treated with Xifaxan for IBS-D included nausea and an increase in alanine aminotransferase, a liver enzyme measured in blood.

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