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Caldolor Approved for Pre-Surgery Pain Relief

Written by Linda S. Hohnholz

A 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.

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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.

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About the author

Linda S. Hohnholz

Linda Hohnholz has been the editor in chief for eTurboNews for many years.
She loves to write and pays great attention to details.
She is also in charge of all premium content and press releases.

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