Caldolor approved for treatment of pain and fever

The FDA has approved Caldolor (intravenous ibuprofen, from Cumberland Pharmaceuticals) for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults. This approval was based on clinical trial data that showed Caldolor to be safe and effective in reducing both pain and fever in 1,400 hospitalized patients. In Phase 3 studies, patients given Caldolor reported a significant reduction in post-surgical pain intensity within the first 24 hours as well as morphine use. In addition, clinical trials including critically ill and non-critically ill patients with fever showed a significant reduction in temperature in patients who received Caldolor compared to those who received placebo.

Caldolor is expected to be available later in 2009.

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