FDA Clears Two Irritable Bowel Syndrome Treatments

The U.S. Food and Drug Administration has cleared two treatments for irritable bowel syndrome with diarrhea, approving drugs that are both linked to recent merger activity in the sector.

Salix Pharmaceuticals Ltd.'s top-selling antibiotic Xifaxan, already approved for traveler's diarrhea, now has approval as an IBS treatment. Valeant Pharmaceuticals International Inc. bought Salix for $11.1 billion in April.

Earlier this year, Sterne Agee estimated the expanded use could add $1 billion in yearly sales.

"We are thrilled to offer patients this new option to manage their IBS-D symptoms," Salix said in a statement.

Xifaxan can be taken orally three times a day for 14 days, according to the FDA.

Actavis PLC's Viberzi, or eluxadoline, was also approved. The drug was the lead product candidate of Furiex Pharmaceuticals Inc. After Actavis PLC agreed to buy Forest Laboratories Inc., Forest announced a deal for Furiex.

Actavis said in September that its new drug application for eluxadoline was granted priority review status, following two Phase 3 trials that met primary endpoints. The product, a twice-daily oral treatment, has mixed opioid receptor activity.

Actavis said Wednesday it is "very pleased to be working with the FDA to advance this IBS-D treatment." The FDA has recommended that Viberzi be classified as a controlled substance. Pending a Drug Enforcement Administration review, the company expects a launch in the first quarter of 2016.

Write to Josh Beckerman at [e-mail]

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