Cumberland Pharmaceuticals, Inc. (CPIX) on Tuesday said it has submitted a supplemental new drug application to the US Food and Drug Administration for the use of Acetadote injection in patients with non-acetaminophen acute liver failure.
The Nashville, Tennessee-based company noted that 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.
Cumberland added that the 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.
Acetadote or acetylcysteine was launched by Cumberland in 2004 as the first US approved injectable drug to treat acetaminophen overdose. Acetadote injection is used in emergency department to prevent or lessen potential liver damage resulting from an overdose of acetaminophen, a common ingredient in many over-the-counter painkillers.
Results from the study, which was noted to be 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".
The study was a multi-center, randomized, double-blind trial involving 173 patients with acute liver failure, which was not due to acetaminophen toxicity. Patients enrolled in the trial were stratified according to coma grade, with coma grade one representing earliest stages of hepatic encephalopathy and coma grade four representing late-stage conditions.
The trial results indicate that 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.
"This study establishes that Acetadote is an excellent treatment for people suffering from non-acetaminophen acute liver failure. Acetadote is safe and easy to administer, and provides the first glimmer of hope that something can help these direly ill patients," said William Lee, professor of internal medicine at UT Southwestern Medical Center and lead author of the study.
Cumberland said the sNDA application is part of a larger effort to support ongoing development of Acetadote for other indications.
In 2006, the FDA approved Acetadote for use in pediatric patients. Later in 2008, Cumberland received FDA approval for updated labeling regarding the safety of Acetadote based on new information from a post-marketing safety study reporting a lower-incidence of side effects compared to previously reported data.
Further, the company said it has requested expanded labeling for Acetadote to include the new indication following discussion of important new data with the FDA. Cumberland has also requested a priority review of the application as well as additional exclusivity for the product if the new indication is approved.
Chief executive officer A.J. Kazimi said, "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."
CPIX is currently trading on the Nasdaq at $11.19 per share, down $0.05 or 0.44%, on a volume of 18,342 shares. In the past 52-week period, the stock has been trading in a range of $10.76 to $17.75.
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