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Cumberland pharm-- publication media release

FOR IMMEDIATE DISTRIBUTION
NEWLY PUBLISHED CLINICAL DATA SHOWS
CALDOLOR (IBUPROFEN) INJECTION REDUCES OPIOID USE WHILE
IMPROVING PAIN RELIEF IN POST-OPERATIVE PATIENTS
¾ Data demonstrates that IV ibuprofen is associated with significant reduction in morphine use in managing pain over immediate 24 hours following surgery ¾ Intravenous ibuprofen also significantly reduces post-operative pain compared to patients with open access to morphine NASHVILLE, Tenn., Oct. 19, 2009 – Cumberland Pharmaceuticals Inc. (Nasdaq:CPIX)
announced today that its Phase III study on intravenous ibuprofen as a post-operative analgesic was
published in Volume 31, Number 9 of the peer-reviewed journal Clinical Therapeutics, distributed
in October. The study concludes that patients emerging from orthopedic and abdominal surgeries
required less narcotic and experienced less pain with 800 mg of intravenous ibuprofen every six
hours compared to morphine alone.
In the United States, approximately 80 percent of patients experience pain following surgery, with
86 percent of these patients reporting moderate to severe pain1,2. Both the World Health
Organization and the American Society of Anesthesiologists Task Force recommend a multi-modal
approach to pain management, with non-opioid analgesics such as ibuprofen recommended as first-
line treatment3,4.
“These clinical findings support the use of intravenous ibuprofen in achieving improved post-
operative pain control,” said Stephen Southworth, M.D., orthopaedic surgeon at the North
Mississippi Sports Medicine & Orthopaedic Clinic, PLLC and lead author of the study. “IV
ibuprofen is a valuable pain management option for physicians seeking a multi-modal approach to
post-operative pain management for their orthopaedic and abdominal patients.”
The goal of this study was to evaluate the safety and efficacy of two different doses of intravenous
ibuprofen as an effective post-operative analgesic medication. It focused on the results of
hospitalized patients undergoing orthopedic or abdominal surgery who were randomized to receive
either a placebo or 400 or 800 mg of intravenous ibuprofen every six hours. All patients had access
to morphine by patient controlled analgesia (PCA). The first dose of ibuprofen was administered
intra-operatively at the initiation of surgical closure. The double-blind, placebo-controlled trial was
conducted at 17 different sites in three countries on 406 patients who were scheduled to undergo
elective, single-site orthopedic or abdominal surgery between February 2005 and September 2006.
Cumberland Pharmaceuticals Announces Publication of Clinical Data Evaluating Caldolor (Ibuprofen) Injection in Treating Post-Operative Pain Median morphine use and pain assessed at rest and with movement were significantly reduced
during the first 24 hours after administration in patients who received the 800-mg dose of ibuprofen.
Pain reduction with Caldolor was also significantly greater versus patients with open access to
morphine.
 
According to the study, "A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of
Intravenous Ibuprofen 400 and 800 mg Every 6 Hours in the Management of Postoperative
Pain," intravenous ibuprofen is safe and well-tolerated when administered intra- and post-
operatively. There was no significant difference between placebo and IV ibuprofen in the number of
patients with renal function abnormalities, bleeding adverse events or in the incidence of blood
transfusions. The publication can be found online at
SOURCE: Cumberland Pharmaceuticals Inc.

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 .

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
markets Acetadote® for the treatment of acetaminophen poisoning and Kristalose®, a prescription
laxative. The Company also recently launched Caldolor®, the first injectable treatment for pain and
fever available in the United States. Cumberland is dedicated to providing innovative products
which improve quality of care for patients. The Company recently completed the initial public
offering of its common stock.
For more information on Cumberland Pharmaceuticals, please visit
About Clinical Therapeutics Journal

Clinical Therapeutics
, published monthly, provides peer-reviewed, rapid publication of original
reports of recent developments in drug therapy, as well as in-depth review articles on specific
drug therapies or disease states. The journal serves an international audience of scientists and
clinicians in a variety of research, academic, and clinical practice settings by quickly
Cumberland Pharmaceuticals Announces Publication of Clinical Data Evaluating Caldolor (Ibuprofen) Injection in Treating Post-Operative Pain disseminating research findings. In addition, the articles are indexed by all major biomedical
abstracting databases.
Published articles range from studies exploring new drugs and new indications for existing drugs
to large, multicenter Phase III and IV trials. In addition to publishing the results of a broad range
of multispecialty clinical studies, the journal features two specialty sections, Pharmaceutical
Economics & Health Policy, which addresses pharmacoeconomic, health outcomes, and
contemporary issues related to drug therapy; and Pediatric Research which addresses matters
regarding safe and effective drug therapy in infants, children, and adolescents. The journal also
encourages submission of brief reports and commentaries on topics that are timely or
provocative.

References

1 Rathmell JP, Wu CL, Sinatra RS, et al. Acute post-surgical pain management: A critical appraisal of current practice,
December 2-4, 2005. Reg Anesth Pain Med. 2006;31(Suppl 1):1-42. 2 Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: Results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97:534-540, table of contents. 3 World Health Organization. Pain relief and palliative care. In: Clinical Management of HIV and AIDS at District Level. New Delhi, India: WHO Regional Office for South-East Asia Web . Updated April 26, 2006. Accessed July 15, 2009. 4 The American Society of Anesthesiologists Task Force. Practice guidelines for acute pain management in the perioperative setting. Anesthesiology. 2004;100(6):1573-1581. Angela Novak Cumberland Pharmaceuticals 615-255-0068 Media Contact: Paula Lovell Lovell Communications 615-297-7766

Source: http://www.greercap.com/clientimages/26054/caldolor008adose-rangingpainstudypublication101909.pdf

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