CALDOLOR® Now FDA Approved for Pre-Operative Administration

Dec 01, 2021 at 03:41 pm by Staff

Dosed prior to surgery, Caldolor® demonstrated significant reduction in pain intensity

Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company 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 non-narcotic pain reliever may now be administered just prior to surgery to enable patients to wake up from their procedure in significantly less pain.

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.

Dr. Stephen Southworth, an orthopedic surgeon at the Orthopedic Institute of North Mississippi concluded that "Caldolor® administered pre-operatively should be considered in Enhanced Recovery After Surgery (ERAS) protocols for the management of postoperative pain including that of traumatic origin. When administered immediately prior to surgery, patients given Caldolor experience less postoperative pain and a decrease in their opioid use."

"Before the pandemic began, healthcare systems across the country were in the midst of a public health mission to control surgical pain while decreasing opioid consumption," said A.J. Kazimi, chief executive officer of Cumberland Pharmaceuticals Inc. "We are proud to see the continued support for Caldolor's use in surgical care, with the product's approved labeling now including the expanded use of the product prior to surgery. We feel confident that this important development provides additional insights into how intravenous ibuprofen can help healthcare professionals and patients as elective surgeries resume."



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