Cumberland Pharmaceuticals Inc.
) recently announced encouraging top-line results from a phase IV
study on Caldolor (the intravenous formulation of ibuprofen) for
the treatment of pain in tonsillectomy patients aged between 6 and
16 years. The study evaluated the safety and efficacy of Caldolor.
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It was found that use of Caldolor leads to a statistically
significant lower number of narcotic doses in post-operative
patients. Caldolor also exhibited efficacy in reducing pain, nausea
The company is also evaluating Caldolor for use in children
suffering from fever and plans to seek approval for a pediatric
indication for Caldolor.
We remind investors that Caldolor is approved by the US Food and
Drug Administration (FDA) had approved Caldolor for the management
of mild to moderate pain, in combination with opioid analgesics for
moderate to severe pain and for the reduction of fever in adults.
However, Caldolor carries a boxed warning regarding an increase in
the risk of serious cardiovascular and gastrointestinal side
effects. It is contraindicated for the treatment of peri-operative
pain in patients undergoing coronary artery bypass graft (CABG)
The other marketed products at Cumberland Pharma are Acetadote
(acetylcysteine) for acetaminophen poisoning and Kristalose, a
In February 2012, the company entered into an agreement with
China's Harbin Gloria Pharmaceuticals Co., Ltd. for the
commercialization of Acetadote and Caldolor in China.
We note that several pharma companies have been working on
expanding their business in China. Some deals include
) joint venture with Zhejiang Hisun Pharmaceuticals for the
development, manufacture and commercialization of off-patent
products in China and across the world,
) joint venture with
) for the development and commercialization of MEDI5117 in China,
) acquisition of Beijing Skywing Technology Co., Ltd. and
) acquisition of a majority stake in Chinese vaccines company
Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.
We currently have an Outperform recommendation on Cumberland
Pharma. The stock carries a Zacks #2 Rank (Buy rating) in the short