ponders for abdominal pain and stool consistency in the primary analysis in Trial 3 (see Table 8).
Table 8. Efficacy Responder Rates in Trial 3 in a Given Week for at Least 2 Weeks During Weeks 3 to 6 of the Double-Blind, First Repeat Treatment Phase
Confidence Intervals were derived based on CMH test adjusting for center and patients’ time to recurrence during maintenance phase. † Primary endpoint
Subjects were IBS-related abdominal pain and stool consistency responders if they were both weekly IBS-related abdominal pain responders and weekly stool consistency responders in a given week for at least 2 weeks during Weeks 3 to 6 in the double-blind first repeat treatment phase. Weekly responder in IBS-related abdominal pain was defined as a 30% or greater improvement from baseline in the weekly average abdominal pain score. Weekly responder in stool consistency was defined as a 50% or greater reduction in the number of days in a week with stool consistency of type 6 or 7 compared with baseline. The p-value for this composite endpoint was <0.05.
Thirty six of 308 (11.7%) of placebo patients and 56 of 328 (17.1%) of XIFAXAN-treated patients responded to the first repeat treatment and did not have recurrence of signs and symptoms through the treatment-free follow-up period (10 weeks after first repeat treatment). The response rate difference was 5.4% with 95% confidence interval (1.2% to 11.6%).
15 REFERENCES
1.Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard Ninth Edition. CLSI document M07-A9. Wayne, PA: Clinical and Laboratory Standards Institute, 2012.
2.Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard Eighth Edition. CLSI document M11-A8. Wayne, PA: Clinical and Laboratory Standards Institute, 2012.
3.Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement. CLSI document M100-S2. Wayne, PA: Clinical and Laboratory Standards Institute, 2014.
16 HOW SUPPLIED/STORAGE AND HANDLING
The 200 mg tablet is a pink-colored, round, biconvex tablet with “Sx” debossed on one side and plain on the other. It is available in the following presentation:
•NDC 65649-301-03, bottles of 30 tablets
The 550 mg tablet is a pink-colored, oval, biconvex tablet with “rfx” debossed on one side and plain on the other. It is available in the following presentations:
•NDC 65649-303-02, bottles of 60 tablets
•NDC 65649-303-03, carton of 60 tablets, Unit Dose
Storage
Store XIFAXAN Tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Persistent Diarrhea
For those patients being treated for travelers’ diarrhea, discontinue XIFAXAN if diarrhea persists more than 24-48 hours or worsens. Advise the patient to seek medical care for fever and/or blood in the stool [see Warnings and Precautions (5.1)].
Clostridium difficile-Associated Diarrhea
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibiotics alters the normal flora of the colon which may lead to C. difficile. Patients can develop watery and bloody stools (with or without stomach cr |
