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:7/12/2017)... July 12, 2017 CarpalAID is a revolutionary new product ... surgery. Carpal tunnel syndrome affects more than 8 million ... the rate of men. The common methods of treating CTS are ... uncomfortable hand braces or gloves. ... CarpalAID is a clear patch worn on ...
(Date:7/11/2017)... 11, 2017  The global market for liquid biopsy ... $394.1 million in 2016.  Although in early stages, the ... in particular as a result of the gradual shift ... recent introduction of a significant number of new liquid ... of tumor biomarkers to guide treatment decisions. ...
(Date:7/10/2017)... July 10, 2017  US medical equipment and supply ... according to Medical Equipment & Supplies: United ... Focus Reports. Continued increases in demand for medical services ... the population and supported by gains in disposable personal ... supplies. New product introductions will also drive sales as ...
Breaking Medicine Technology:
(Date:7/20/2017)... ... July 20, 2017 , ... LINET, an international leader in ... their product line: the AVE 2 birthing bed. , Perfectly suitable for labor, delivery, ... level of comfort and efficiency to every phase of childbirth. The AVE 2 has ...
(Date:7/20/2017)... ... July 19, 2017 , ... Dr. Jig Patel is pleased to ... with or without a referral. Understanding the difficulties that face people who are ... choose this permanent alternative to removable dentures and bridges. Not only does an implant ...
(Date:7/20/2017)... ... July 19, 2017 , ... Med Tech Solutions (MTS), ... based Health IT business unit of Constellation Inc., a move that will help the ... of operations in St. Louis, the acquisition is expected to help MTS ...
(Date:7/20/2017)... , ... July 19, 2017 , ... ... recently hiring senior healthcare project manager, Josh Christensen. As a leader in healthcare ... looks to further its healthcare resume in the Midwest with Josh now on ...
(Date:7/20/2017)... ... July 19, 2017 , ... A July 7th ... or worsen, varicose veins in some patients, according to medical experts. Washington State ... practices, like excessive sitting or standing, or regularly nicking yourself while shaving your ...
Breaking Medicine News(10 mins):