By Chris Wack

 

Cumberland Pharmaceuticals Inc. shares doubled to $4.49 in heavy trade 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.

Volume for the stock was 131.2 million shares at 12:35 p.m. ET, compared to its 65-day average volume of 322,000 shares. The company has a public float of 8.3 million shares. The stock hit its 52-week high of $5.48 earlier in the session, and it 52-week low of $2.20 on Monday.

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 12:54 ET (17:54 GMT)

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