Salix' s Xifaxan 550 sNDA Under Review, Response by Feb 28

Salix Pharmaceuticals, Ltd.’s (SLXP) supplemental new drug application (sNDA) for Xifaxan 550 has been accepted for review by the FDA. The company is looking to expand the use of Xifaxan 550 for the treatment of irritable bowel syndrome with diarrhea (IBS-D).

With the resubmitted sNDA being treated as a class 2 response, a decision from the FDA regarding the approval status of the drug should be out by Feb 28, 2015.

We remind investors that Salix had earlier received a complete response letter (CRL) from the FDA for this indication. In keeping with the requirements, the company conducted a randomized, double-blind, placebo-controlled phase III study – TARGET 3 – to evaluate the efficacy and safety of repeat treatment with Xifaxan 550 mg thrice daily for 14 days in subjects with IBS-D who had responded to an initial 14-day treatment course with Xifaxan 550 mg thrice daily. Salix reported positive results from this study in Jul 2014.

Xifaxan 550 is currently approved for the reduction in risk of overt hepatic encephalopathy recurrence in adults. Approval for the IBS-D indication would boost Xifaxan 550 sales significantly.

Meanwhile, Salix has an important regulatory event coming up this month with the FDA slated to decide on the approval of Relistor for the treatment of opioid-induced constipation (:OIC) in patients taking opioids for chronic non-cancer pain. Earlier this week, the FDA had approved AstraZeneca (AZN) and Nektar Therapeutics’ (NKTR) Movantik for this indication.

Salix is a Zacks Rank #4 (Sell) stock. Some better-ranked stocks in the health care sector include Endo International plc (ENDP). Endo is a Zacks Rank #1 (Strong Buy) stock.

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