Newly Published Clinical Data Shows Caldolor (Ibuprofen) Injection Reduces Opioid Use While Improving Pain Relief in Post-Operative Patients
-- Data demonstrates that IV ibuprofen is associated with significant reduction in morphine use in managing pain over immediate 24 hours following surgery -- Intravenous ibuprofen also significantly reduces post-operative pain compared to patients with open access to morphine
NASHVILLE, Tenn., Oct. 19 /PRNewswire-FirstCall/ -- 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 pain(1,2). 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 treatment(3,4).
"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.
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 www.clinicaltherapeutics.com.
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 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 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
www.cumberlandpharma.com.
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
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 site.
http://www.searo.who.int/linkfiles/publications_ch11.pdf.
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.
Source: Cumberland Pharmaceuticals Inc.
CONTACT: Investors, Angela Novak of Cumberland
Pharmaceuticals,
+1-615-255-0068, investors@cumberlandpharma.com;
or Media, Paula Lovell of
Lovell Communications, +1-615-297-7766, lovell@lovell.com, for
Cumberland
Pharmaceuticals Inc.
Web Site: http://www.cumberlandpharma.com/
http://www.caldolor.com/
Posted: October 2009
