Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

The sNDA includes data from a clinical trial led by investigators at the University of Texas Southwestern Medical Center indicating that acute liver failure patients treated with Acetadote have a significantly improved chance of survival without a transplant. These patients can also survive a significant number of days longer without transplant, providing patients requiring transplant increased time for a donor organ to become available.

"This study establishes that Acetadote is an excellent treatment for people suffering from non-acetaminophen acute liver failure," said William M. Lee, M.D., professor of internal medicine at UT Southwestern Medical Center in Dallas and lead author of the study. "Acetadote is safe and easy to administer, and provides the first glimmer of hope that something can help these direly ill patients."

The results from the study, which is the largest clinical trial studying acute liver failure to date, were presented at the most recent national gastroenterology meeting and have been published in the medical journal Gastroenterology(1). This was a multi-center, randomized, double-blind trial involving 173 patients with acute liver failure not due to acetaminophen toxicity. Patients enrolled in the study were stratified according to coma grade, with coma grade one representing the earliest stages of hepatic encephalopathy and coma grade four representing late-stage conditions. The study results indicate that the transplant-free survival rate was significantly higher at three weeks, one year and two years for patients in coma grades one and two receiving Acetadote than for those receiving placebo.

"We are pleased to take the next step in expanding the use of this important product," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Since its approval in 2004, Acetadote has become a standard of care for treating liver damage associated with acetaminophen overdose. If approved for this new indication, we believe Acetadote will bring potentially life-saving treatment to a broader group of patients who have few alternatives."

Cumberland requested expanded labeling for Acetadote to include the new indication following discussion of the important new data with the FDA. The Company has requested a priority review of the application as well as additional exclusivity for the product if the new indication is approved.

The sNDA application is part of a larger effort to support ongoing development of Acetadote for other indications where the product can provide benefit. In 2006, the FDA approved Acetadote for use in pediatric patients. The Company also received FDA approval for updated labeling regarding the safety of Acetadote in 2008 based on new information from a post-marketing safety study reporting a lower-incidence of side effects compared to previously reported data.

SOURCE Cumberland Pharmaceuticals Inc.