Actavis plc ACT announced that the FDA approved Viberzi (eluxadoline) as a twice-daily, oral treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D).

Approximately 15 million adults in America are estimated to be affected by IBS-D. Currently, there are only few treatment options that relieve both the diarrhea and abdominal pain associated with IBS-D. Hence, the market opportunity is immense for the drug.

However, the FDA has recommended that Viberzi should be classified as a controlled substance. The agency has submitted its recommendation to the U.S. Drug Enforcement Administration. The updated label will be available once Viberzi receives final scheduling designation. A tentative product launch is anticipated in the first quarter of 2016.

We remind investors that Viberzi became part of Actavis’ portfolio through its acquisition of Furiex Pharmaceuticals, Inc in Jul 2014.

Actavis, a strong player in the generics market, has been actively pursuing acquisitions over the past few years and has been working on expanding its presence in the branded market. The latest Allergan acquisition has placed Actavis among the top 10 pharmaceutical companies in the world based on sales.

Meanwhile, Valeant Pharmaceuticals International, Inc. VRX received FDA approval for Xifaxan 550 mg for the treatment of IBS-D in adults. Hence, Viberzi stands to face stiff competition upon launch in the U.S.

Actavis currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Actelion Ltd. ALIOF and Gilead Sciences Inc. GILD. Both carry a Zacks Rank #1 (Strong Buy).

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