Cumberland Pharmaceuticals, Inc. (CPIX) Wednesday said it has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its supplemental new drug application for Acetadote Injection to treat patients with non-acetaminophen induced acute liver failure.
Acetadote or acetylcysteine, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. The agency elaborated that the patients with Coma Grade I/II observed a numerically higher rate of transplant-free survival, but also noted that there was not sufficient evidence of efficacy for the proposed indication of increasing survival in all patients with acute liver failure.
The sNDA for the new indication, filed in March, found 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.
In October, Cumberland submitted an application to the FDA for approval of a new, second generation formulation of Acetadote, which is designed to replace the currently marketed product. The company is currently supporting FDA review of that application and expects to receive agency response regarding the new formulation by early January 2011.
For comments and feedback: editorial@rttnews.com