Cumberland Pharmaceuticals Shares Double, Hit 52-Week High
01 December 2021 - 05:09AM
Dow Jones News
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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