Cumberland Pharmaceuticals Inc.announced the publication of data from a clinical trial evaluating the pharmacokinetics, safety and tolerability of a rapid infusion of Caldolor® (ibuprofen) Injection compared to oral ibuprofen. The study, which was published in the January issue of American Journal of Health-System Pharmacy, demonstrated that the maximum plasma concentration (Cmax) of IV ibuprofen when administered over five to seven minutes was approximately twice that of oral ibuprofen. In addition, the time to the maximum plasma concentration (tmax) of IV ibuprofen was 6.5 minutes compared with 1.5 hours for oral ibuprofen. The study results indicated that the rapid infusion of IV ibuprofen was both safe and well tolerated. Caldolor, which was approved by the U.S. Food and Drug Administration in 2009, is the only U.S. approved injectable ibuprofen product and is indicated for the treatment of pain and fever in adults. In previous clinical trials Caldolor has been shown to significantly improve pain control while also reducing opioid requirements in the post-operative setting, as well as to significantly reduce fever in hospitalized patients. These previously published studies found the product to be safe and effective in treating pain and ever when administered over 30 to 60 minutes. The newly published data demonstrates the product’s ability to be infused over a shorter period of time.
Leo Pavliv, Cumberland’s Senior Vice President of Operations and lead author of the study said, Shorter infusion time of injectable analgesics and antipyretics could hasten onset of action. Speeding delivery of IV ibuprofen prior to and following a surgical procedure provides more convenient dosing to accomplish preemptive analgesia and post-operative, opioid-sparing pain control as well as anti-inflammatory effects — all of which help treat pain at its source.