Cumberland announced results from two Phase 4 studies that support the efficacy and tolerability of a shortened infusion time of Caldolor (ibuprofen) injection. The study results are available in the journal Clinical Therapeutics.
The first study, “The Shortened Infusion Time of Intravenous Ibuprofen Part 1: A Multicenter, Open-Label, Surveillance Trial to Evaluate Safety and Efficacy,” enrolled 150 hospitalized patients with mild to severe pain or a fever >101.0ºF. The second study, “The Shortened Infusion Time of Intravenous Ibuprofen Part 2: A Multicenter, Open-Label, Surgical Surveillance Trial to Evaluate Safety and Efficacy,” enrolled 300 patients schedule for elective surgical procedures.
Results from the first study showed the safety and efficacy of Caldolor injection in reducing pain and temperatures, supporting its use in hospitalized patients. Results from the second study supported the safety of a shortened infusion time in surgical patients when started at induction of anesthesia. Caldolor provided pain reduction similar to that shown in previous studies.
Both studies allowed for the infusion of multiple doses of intravenous (IV) ibuprofen and showed that the shortened administration time of 5-10 minutes was well tolerated.
Caldolor is an IV non-steroidal anti-inflammatory drug (NSAID) indicated for the management of mild to moderate pain, management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in adults.
For more information call (877) 485-2700 or visit Caldolor.com.