Salix Pharmaceuticals Receives FDA Approval for Xifaxan® 550 mg for the Treatment of IBS-D (Irritable Bowel Syndrome with Diarrhea)

Valeant Pharmaceuticals International Inc. (TSX:VRX,NYSE:VRX) announced that its wholly owned subsidiary Salix Pharmaceuticals Inc. (NASDAQ:SLXP), has received FDA approval for Xifaxan® 550 mg for the treatment of Irritable bowel syndrome with diarrhea (IBS-D) in adults.

As quoted in the press release:

The FDA approval of Xifaxan 550 mg is based on data from three phase 3 studies, TARGET 1, TARGET 2 and TARGET 3. Xifaxan 550 mg was studied in over 3,000 patients and demonstrated the efficacy and safety of repeat treatment following completion of a two-week course of treatment. A full course of Xifaxan 550 mg for IBS-D is available in a convenient 2 week pack of 42 pills.

As many as 35 million adult Americans may experience IBS, and 40% of people with IBS suffer from diarrhea-prominent symptoms that include urgency, loose, watery stools and abdominal pain.^i,ii,iii  Although millions suffer from the condition, current treatments for IBS-D are limited to products aimed at relieving individual symptoms (e.g., antispasmodics, anti-diarrheal agents, bulking agents, anti-flatulence agents) and fail to address the syndrome complex.

The FDA approval was based on data from three clinical studies of more than 3,000 patients. Results of TARGET 1 and 2 showed patients treated with Xifaxan 550 mg achieved relief of the FDA composite endpoint (stool consistency and abdominal pain) versus placebo. TARGET 3 showed that patients who responded to treatment with Xifaxan 550 mg but experienced recurrent symptoms responded to repeat treatment in the FDA composite endpoint versus placebo.

Mark Pimentel, director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai, commented:

As a gastroenterologist who helps patients navigate the symptoms of IBS-D, I see the need for treatments that directly address those most bothersome, such as diarrhea and abdominal pain. Today’s approval gives a new option to these patients and providers.

Bill Forbes, president, medical, R&D and chief development officer at Salix, commented:

We are thrilled to offer patients this new option to manage their IBS-D symptoms. The FDA approval in IBS-D extends the reach of Xifaxan 550 mg beyond hepatic encephalopathy to a population greatly in need of a different treatment approach.

Click here to read the full Valeant Pharmaceuticals International Inc. (TSX:VRX,NYSE:VRX) press release.