Navigation Links
Caldolor(R) (Ibuprofen) Injection Demonstrates Significant Fever Reduction in Hospitalized Burn Patients
Date:11/23/2009

NASHVILLE, Tenn., Nov. 23 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. ( 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.


'/>"/>
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cumberland Pharmaceuticals and Phebra Pty Ltd. Sign Exclusive Agreement for Commercialization of Caldolor(R) in Australia and New Zealand
2. Caraco Pharmaceutical Laboratories, Ltd. Markets Nicardipine Hydrochloride Injection
3. Bioniche Pharma and Academic Pharmaceuticals, Inc. Announce the Introduction of Sotalol Hydrochloride Injection
4. LUSEDRA(TM) (fospropofol disodium) Injection CIV for Monitored Anesthesia Care (MAC) Sedation Now Available
5. American Regent Expands Voluntary Recall to Include All Lots of Ketorolac Tromethamine Injection, USP 15 mg/mL; 1mL Single Dose Vials
6. Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDAs BYETTA(R) (Exenatide) Injection Update
7. Sagent Pharmaceuticals Launches Vinorelbine Injection, USP
8. Sagent Pharmaceuticals Announces Launch of Adenosine Injection, USP, in 6 mg per 2 mL Single-Dose Vials
9. Injection Reverses Heart-Attack Damage
10. FDA Accepts sNDA for Alternative Dosing Regimen for Dacogen(R) (decitabine for injection) to Treat Patients with Myelodysplastic Syndromes (MDS)
11. Study Showed Lillys GEMZAR(R) (gemcitabine HCl for injection) Improved Progression-Free Survival in Cervical Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... SAN FRANCISCO , Feb. 11, 2016 Potrero ... system, is pleased to announce the appointment of George ... San Antonio, TX , WellMed is ... servicing over 200,000 patients and HMO members in ... founding WellMed in 1990 out of his own internal medicine ...
(Date:2/11/2016)... Feb. 11, 2016  MiMedx Group, Inc. (NASDAQ: ... amniotic membrane and other birth tissues, human skin and ... and market advanced products and therapies, announced today that ... Global Healthcare Conference in New York ... Michael J. Senken , Chief Financial Officer and ...
(Date:2/11/2016)...  AfterPill.com is reporting that this week,s Centers for ... women who are at risk of unintended pregnancy impacts ... raises the risks of unprotected sex in particular.  ... to the Guttmacher Institute, there are 43 million women ... who have sex without the intention of becoming pregnant.  ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... February 11, 2016 , ... According to an article published February ... loss dietary supplement, is being recalled due to the discovery that it contains dangerous ... not a single supplement on the market proven to help people safety lose excess ...
(Date:2/11/2016)... , ... February 11, 2016 , ... Registered nurses, licensed ... CEU seminar titled, “Stroke Management: Time to Act, Time to Heal” on Thursday, February ... in Whippany, N.J. The presenter is Vishal Chedda, president of ANSA Consultants, who will ...
(Date:2/11/2016)... (PRWEB) , ... February 12, 2016 , ... The ... is up from 0.416 in 2013. The SJR uses data taken from the Scopus ... account both the number of citations received by the journal over a three year ...
(Date:2/11/2016)... ... 11, 2016 , ... The Chartis Group, a national advisory ... in the “2015/2016 Best in KLAS: Software and Services” report in two categories: ... and insights firm on a global mission to improve healthcare delivery by amplifying ...
(Date:2/11/2016)... ... February 11, 2016 , ... Thermi™, a world leader ... to announce the promotions of Allison Kelly to executive vice president of the ... vice president of North American capital sales, and Wendy Oseas to vice president ...
Breaking Medicine News(10 mins):