Caldolor will be used primarily in hospitalized patients who are unable to receive oral therapies for pain relief and fever reduction. The only injectable drugs currently available to reduce pain are opioids, such as morphine and meperdine, and ketorolac, a non-steroidal anti-inflammatory drug. Opioids can cause sedation, nausea, vomiting, cognitive impairment, and respiratory depression.

Ken Holroyd, Assistant Vice Chancellor for Research and Associate Professor of Anesthesiology & Medicine at Vanderbilt University says, The approval of Caldolor gives physicians, long comfortable with the use of oral ibuprofen formulations, an alternative therapy for pain and fever in the hospital setting where an injectable medicine is often needed.  

Caldolor is the third drug in Cumberland's portfolio and the second for which Cumberland has completed development and secured FDA approval. The company will promote Caldolor in the United States through its expanded hospital sales force and will use alliances with marketing partners for sales outside of the United States. Caldolor is expected to be available in the U.S.
later this year.