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FDA Issues Complete Response Letter Regarding Acetadote® Supplemental New Drug Application for Acute Liver Failure
Date:12/22/2010

by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have an improved chance of survival without a transplant. The study also demonstrated that these patients can survive a significant number of days longer without transplant, providing patients requiring transplant increased time for a donor organ to become available. Patients were stratified according to Coma Grade, with Coma Grade I representing the earliest stages of liver failure and Coma Grade IV representing late-stage conditions. Analyses presented in Cumberland's sNDA indicate that transplant-free survival was significantly higher at three weeks, one year and two years for patients in Coma Grades I and II receiving Acetadote than for those receiving placebo. The results from the study, which is the largest clinical trial studying acute liver failure to date, were published in the medical journal Gastroenterology(1).

Cumberland's request to expand labeling for Acetadote to include the new indication followed a discussion of this data with the FDA. The Company requested and was granted a priority review for the application.

This sNDA is part of Cumberland's commitment to support ongoing development of Acetadote and its other products. Acetadote was initially launched by Cumberland in 2004 as the first injectable drug to treat acetaminophen overdose approved in the United States. Since then, Acetadote has become a standard of care in treating acetaminophen poisoning, which is the leading cause of toxic drug ingestions reported to U.S. poison control centers(2). In 2006, the FDA approved Acetadote for use in pediatric patients. Cumberland also received FDA approval for updated safety labeling for Acetadote in 2008 based on information from a post-marketing safety study reporting a lower incidence of side effects compared to previously reported data.

In October 2010, Cumberland submitted an appli
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SOURCE Cumberland Pharmaceuticals Inc.
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