Caldolor® Reduces Pain And Fever In Adult Patients

              Caldolor® Reduces Pain And Fever In Adult Patients

- Studies support shortened Caldolor infusion time

- Studies conducted at 35 leading medical centers

PR Newswire

NASHVILLE, Tenn., Feb. 19, 2013

NASHVILLE, Tenn., Feb. 19, 2013 /PRNewswire/ --Cumberland Pharmaceuticals
Inc. (NASDAQ: CPIX) today  announced top-line results from two registry
studies evaluating the safety and efficacy of Caldolor® (ibuprofen) Injection
administered over a shortened infusion time in treating pain and fever in
adult patients. The studies involved 450 patients receiving Caldolor at 35
leading medical centers throughout the United States.

The first of two registry studies was a phase IV multi-center, open-label
surveillance clinical study to assess the safety and efficacy of ibuprofen
administered intravenously over five to ten minutes to adult patients in the
hospital setting with temperature fever (>101°F) and/or pain (visual analog
scale (VAS) assessment >3). Eligible patients were enrolled to receive one of
two dose strengths (400 mg for treatment of fever, 800 mg for treatment of
pain) of intravenous ibuprofen for up to a 24-hour dosing period. One hundred
fifty patients from 13 clinical sites were enrolled in this study. Intravenous
ibuprofen reduced fever and pain and the shortened infusion time was well
tolerated.

The second of two registry studies was a phase IV multi-center, open-label
surveillance clinical study to assess the safety of ibuprofen administered
intravenously over five to ten minutes to adult hospitalized patients
undergoing surgical procedures. Eligible patients were enrolled to receive 800
mg intravenous ibuprofen administered at induction of anesthesia and could
continue Caldolor therapy for up to 24 hours. Three hundred patients from 21
clinical sites were enrolled in this study. The shortened infusion time was
well tolerated.

"We are pleased to complete these two important studies supporting the safety
of a shortened Caldolor infusion time," said A.J. Kazimi, Chief Executive
Officer of Cumberland Pharmaceuticals. "We remain committed to the ongoing
development of our brands and expanding the patient safety database for our
products."

About Caldolor

Caldolor is indicated for the management of mild to moderate pain and
management of moderate to severe pain as an adjunct to opioid analgesics, and
for the reduction of fever in adults. It is the first FDA approved intravenous
therapy for fever. Caldolor is contraindicated in patients with known
hypersensitivity to ibuprofen or other NSAIDs, patients with asthma,
urticaria, or allergic type reactions after taking aspirin or other NSAIDs.
Caldolor is contraindicated for use during the peri-operative period in the
setting of coronary artery bypass graft (CABG) surgery. Caldolor should be
used with caution in patients with prior history of ulcer disease or GI
bleeding, in patients with fluid retention or heart failure, in the elderly,
those with renal impairment, heart failure, liver impairment, and those taking
diuretics or ACE inhibitors. Blood pressure should be monitored during
treatment with Caldolor. For full prescribing information, including boxed
warning, visit www.caldolor.com.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a Tennessee-based specialty pharmaceutical
company focused on the acquisition, development and commercialization of
branded prescription products. The Company's primary target markets include
hospital acute care and gastroenterology. Cumberland's marketed products
include Acetadote® (acetylcysteine) Injection for the treatment of
acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable
treatment for pain and fever approved in the United States, and Kristalose®
(lactulose) for Oral Solution, a prescription laxative. Cumberland is
dedicated to providing innovative products which improve quality of care for
patients. For more information, visit the Company's website at
www.cumberlandpharma.com.

Important Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that reflect
Cumberland's current views on future events, based on what it believes are
reasonable assumptions. No assurance can be given that these events will
occur. As with any business, all phases of operations are subject to
influences outside of the Company's control. Risk factors that could
materially affect results of operations include market conditions, competition
from existing and new products, an inability or failure of manufacturers to
produce the Company's products on a timely basis or to comply with stringent
regulations applicable to drug manufacturers, maintaining and building an
effective sales and marketing infrastructure, government regulation, the
possibility that patent rights may provide limited protection from
competition, and other factors including those under the headings "Risk
factors" and "Management's discussion and analysis of financial condition and
results of operations" in Cumberland's Form 10-K filed with the SEC on March
11, 2011. There can be no assurance that results anticipated by Cumberland
will be realized or, if realized, that they will have the expected effects.
Readers are cautioned not to place undue reliance on forward-looking
statements, which speak only as of the date hereof. Cumberland undertakes no
obligation to release publicly any revisions to these statements to reflect
events or circumstances after the date hereof.

SOURCE Cumberland Pharmaceuticals Inc.

Website: http://www.cumberlandpharma.com
Website: http://www.caldolor.com
Contact: Investors, Elizabeth Davis, Corporate Relations, Cumberland
Pharmaceuticals, +1-615-255-0068, edavis@cumberlandpharma.com; or Media,
Rebecca Kirkham, Lovell Communications, +1-615-297-7766, rebecca@lovell.com
 
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