Tennessee based, Cumberland has announced that FDA has approved Caldolor, an intravenous formulation of ibuprofen, through a priority review. Caldolor is indicated for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever in adults.
Caldolor will be used primarily in hospitalized patients who are unable to receive oral therapies for pain relief and fever reduction, said the company.
Clinical trials, which included critically ill and non-critically ill patients with fever showed a significant reduction in temperature as compared with those who received a placebo. No serious adverse events were directly attributed to Caldolor in any of these clinical studies.
A.J. Kazimi, CEO of Cumberland, said: We are delighted to obtain FDA approval for the first and only intravenous treatment for pain and fever in the US market. We believe Caldolor represents a significant addition to our product portfolio and a substantial market opportunity.”