Zacks_Analysts' Blog : Setback for Cumberland Pharma - Analyst Blog

Recently, Cumberland Pharmaceuticals, Inc. (CPIX) encountered a huge blow on the US Food and Drug Administration (FDA) refusing to approve its liver failure injectable drug, Acetadote, for an additional indication due to insufficiency of data. Acute liver failure is associated with a high mortality rate and liver transplantation is often needed to combat the disorder.

The US regulatory agency declined to approve Acetadote in patients with non-acetaminophen acute liver failure and issued a complete response letter (CRL). While issuing the CRL, the regulatory agency stated that there was insufficient evidence of efficacy in prolonging survival in patients suffering from acute liver failure. Management at Cumberland Pharma stated that it intends to meet the FDA regarding the objections raised by the FDA.

We remind investors that Cumberland Pharma filed the application with the FDA to expand the label of Acetadote in March 2010. The company filed a supplemental new drug application seeking approval to market Acetadote injection in patients with non-acetaminophen acute liver failure.

In October 2010, Cumberland Pharma filed an application with the FDA seeking approval to market a new formulation of Acetadote. A response from the FDA regarding this application is expected by January next year. We note that Acetadote has already hit the market to counteract overdoses of acetaminophen.

Apart from Acetadote, the other marketed products at Cumberland Pharma, which carries a Zacks #3 Rank (short-term ‘Hold’ rating), are Kristalose, a prescription laxative and Caldolor (ibuprofen) for the treatment of pain and fever. The company competes with players such as Hospira Inc. (HSP).