By Chris Wack

 

Cumberland Pharmaceuticals Inc. shares doubled to $4.79 in premarket trading after the company said the U.S. Food and Drug Administration has approved expanded labeling for Caldolor, an intravenously delivered formulation of ibuprofen, to now include use in pre-operative administration.

The specialty pharmaceutical company said 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.

Cumberland said the expanded use of Caldolor is supported by a study of orthopedic surgical pain, which confirmed the significant pain reduction when the product was administered every six hours with supplemental morphine available 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 with those receiving placebo.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

November 30, 2021 06:36 ET (11:36 GMT)

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