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Allergan’s Irritable Bowel Drug Viberzi Approved in Canada


Allergan plc AGN announced that Health Canada has approved Viberzi (eluxadoline) for the treatment of adults suffering with irritable bowel syndrome with diarrhea(IBS-D). The drug is marketed in the U.S. and Europe as a twice-daily, oral treatment.

A look at the company’s share price movement shows that the stock has outperformed the Zacks classified Medical – Generic Drugs industry this year so far. Allergan’s shares gained 6.9% during this period, while the industry registered a decrease of 5.2%.

The approval from Health Canada is based on results from two phase III clinical trials evaluating Viberzi over 26 and 52 weeks for a composite response of decrease in abdominal pain and improvement in stool consistency on the same day for at least 50% of the days from weeks one through 12 and from weeks one through 26. The data from the two pivotal studies published in the New England Journal of Medicine showed a significant reduction in abdominal pain and diarrhea in one to four weeks when treated with Viberzi. The patients experienced sustained relief over the period of the study.

Approximately 2 million adults in Canada are estimated to be affected by IBS-D. As per one gastroenterologist in Toronto, the treatment options that are currently available are not satisfactory for many patients as they continue to experience irritations. Hence, Viberzi has significant opportunity for growth.

Viberzi put up a robust performance in 2016 with sales of $93.3 million. However, Valeant Pharmaceuticals International, Inc. VRX sells Xifaxan for the same indication.

Meanwhile, Allergan already markets another irritable bowel syndrome drug, Linzess. The company along with its partner, Ironwood Pharmaceuticals, Inc. IRWD markets Linzess for the treatment of irritable bowel syndrome with constipation (IBS-C). Allergan is evaluating Linzess for better treatment of IBS-C by targeted delivery through delayed release.

However, competition in the IBS-C market has intensified with the FDA approval of Synergy Pharmaceuticals Inc.’s SGYP Trulance for the same indication in Jan 2017.

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