Xifaxan® 550 mg is the first-and-only nonsystemic antibiotic approved for the treatment of IBS-D in adults
Valeant Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced that its wholly owned subsidiary, Salix Pharmaceuticals, Inc., has received approval from the U.S. Food and Drug Administration (FDA) for Xifaxan® 550 mg for the treatment of IBS-D in adults. 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 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" said Dr. Mark Pimentel, director of the Gastrointestinal Motility Program and Laboratory at Cedars-Sinai in Los Angeles. "Today's approval gives a new option to these patients and providers."
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. 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 Xifaxan 550 mg approval gives patients access to a treatment that may alleviate their symptoms," said Dr. Costas H. Kefalas, president and member of the Board of Directors of the Digestive Disease National Coalition (DDNC). "This treatment is in line with the DDNC's mission to provide improved access to quality digestive health care."
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.
"We are thrilled to offer patients this new option to manage their IBS-D symptoms," said Bill Forbes, PharmD, president, medical, R&D and chief development officer of Salix. "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."
Xifaxan 550 mg offers a safety and tolerability profile comparable to placebo when used as directed.
Xifaxan is also FDA-approved to manage hepatic encephalopathy (550 mg). Recommended dosing for Xifaxan 550 mg for IBS-D is one 550 mg tablet three times a day for 14 days. Patients can take up to two additional courses if IBS-D symptoms recur in the future. Xifaxan 550 mg is currently available to patients.
Valeant Pharmaceuticals International, Inc.