Study Arm Evaluating 40 MG BID of Rifaximin SSD IR In Combination with Standard of Care Therapy Met Primary Endpoint
LAVAL, Quebec, March 31, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") today announced topline results from a Phase 2 study evaluating an investigative soluble solid dispersion (SSD) formulation of immediate release (IR) rifaximin in combination therapy with the current standard of care therapy, lactulose, for the treatment of Overt Hepatic Encephalopathy (OHE).
In the double-blinded, placebo-controlled multi-arm, dose-ranging study, the treatment arm evaluating 40 mg BID of rifaximin SSD IR plus standard of care therapy met its primary endpoint of time to resolution of OHE using the Hepatic Encephalopathy Grading Instrument (HEGI) scale. The 40 mg BID rifaximin SSD IR in combination with standard of care therapy treatment arm was statistically significantly superior to the placebo plus standard of care therapy treatment arm with median time to resolution being 21.1 hours versus 62.7 hours, respectively. The rates of adverse events were comparable across all treatment arms of the study.
"The topline results of this study will help inform further research on potential new indications for rifaximin using this formulation," said Joseph C. Papa, chairman and CEO, Bausch Health. "Our R&D team will continue to analyze the full results of this dose-ranging study for further insights and present them in an upcoming scientific forum."
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.
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SOURCE Bausch Health Companies Inc.