Cumberland Pharmaceuticals Inc., a specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved expanded labeling for Caldolor®, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration.
The newly FDA-approved label includes information regarding the product’s indications and usage, appropriate patient populations, clinical study results, potential side effects, patient safety details, and instructions for use in pregnant women, children and other populations.
Supporting this expanded use of Caldolor, a study of orthopedic surgical pain confirmed the significant pain reduction when the product was administered every six hours (started pre-operatively) with supplemental morphine available on an as needed basis. A total of 185 patients were randomized and treated with either Caldolor® 800 mg or placebo administered every six hours (started pre-operatively) and morphine provided on an as needed basis.
Efficacy was demonstrated as a statistically significant greater reduction in pain intensity over 24 hours post-operatively for patients treated with Caldolor® as compared to those receiving placebo.