Caldolor (Ibuprofen) Injection Demonstrates Significant Fever Reduction in Hospitalized Burn Patients
New data supports safety of Caldolor over 5 days of treatment
NASHVILLE, Tenn., Nov. 23 /PRNewswire-FirstCall/ -- Cumberland
Pharmaceuticals Inc. (NASDAQ:CPIX) today announced positive new
top-line results from a study evaluating the safety and efficacy of
Caldolor (ibuprofen) Injection in treating fever in hospitalized
burn patients.
Statistical significance was achieved for the primary endpoint
of reducing fever in burn patients over the first 24 hours of
treatment. The study evaluated 61 adult burn patients with second
or third degree burns covering more than 10 percent total body
surface area. Other participant criteria included an anticipated
hospital stay of more than 72 hours and temperatures of 38.0
degrees C (100.4 degrees F) or greater.
Patients were administered 800mg of Caldolor every six hours for
five consecutive days.
The study raised no safety concerns and the medication was well
tolerated. There was no difference in adverse effects between
patients who received a placebo and those receiving Caldolor.
According to the American Burn Association, 1.1 million burn
injuries require medical attention each year in the United States.
Of these, approximately 50,000 burn injuries require
hospitalization, 20,000 are major burn injuries affecting 25
percent of total body surface area and 4,500 people die. In
addition, up to 10,000 people in the United States die every year
from burn-related infections.(1)
"Hospitalized burn patients often suffer from both fever and
pain and our review of this data, along with results from our
previous clinical work, supports our belief that Caldolor can be
extremely helpful in treating these patients," said A.J. Kazimi,
Chief Executive Officer of Cumberland Pharmaceuticals. "Further, we
are thrilled to reaffirm that Caldolor can be administered to
hospitalized patients for five consecutive days with no safety
issues."
The multicenter, randomized, double-blind, placebo-controlled
trial was conducted at five U.S. and international clinical sites,
including hospital burn units and burn centers. As with previous
clinical trials, Cumberland Pharmaceuticals plans to submit the
results of this study for publication as well as for medical
meeting presentation.
SOURCE: Cumberland Pharmaceuticals Inc. 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 product portfolio includes
Acetadote® (acetylcysteine) Injection for the treatment of
acetaminophen poisoning and Kristalose® (lactulose) for Oral
Solution, a prescription laxative. The Company also recently
launched Caldolor® (ibuprofen) Injection, 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 completed the
initial public offering of its common stock in August 2009. For
more information on Cumberland Pharmaceuticals, please visit
www.cumberlandpharma.com.
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.
References
(1) American Burn Association (2002). Burn Incidence Fact
Sheet.
Source: Cumberland Pharmaceuticals Inc.
CONTACT: Investor: Angela Novak of Cumberland
Pharmaceuticals,
+1-615-255-0068, investors@cumberlandpharma.com;
or Media: Paula Lovell of
Lovell Communications, +1-615-972-2964, lovell@lovell.com
Web Site: http://www.cumberlandpharma.com/
Posted: November 2009
