Caldolor® Studies to be Presented at the Annual Meeting of the American Society of Anesthesiologists
NASHVILLE, Tenn., Oct. 10, 2013 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that data from three recent studies evaluating the safety and efficacy of Caldolor® (ibuprofen) Injection will be presented at the Annual Meeting of the American Society of Anesthesiologist in San Francisco.
Poster presentations will be presented by Dr. Alberto Uribe, Post Doctoral Researcher, Department of Anesthesiology, Wexner Medical Center at The Ohio State University. A poster presentation entitled "Multicenter, Open-label Surveillance Trials to Evaluate the Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen" will be on Monday, October 14th, at 8:00 a.m.PST.
Two registry studies make up this presentation. The first registry study eligible patients were enrolled to receive one of two dose strengths (400 mg for treatment of fever, 800 mg for treatment of pain) of intravenous ibuprofen for up to a 24- hour dosing period. One hundred fifty patients from 13 clinical sites were enrolled in this study. Intravenous ibuprofen reduced fever and pain and the shortened infusion time was well tolerated.
The second registry study that was a phase IV multi-center, open-label surveillance clinical study to assess the safety of ibuprofen administered intravenously over five to ten minutes to adult hospitalized patients undergoing surgical procedures. Eligible patients were enrolled to receive 800 mg intravenous ibuprofen administered at induction of anesthesia and could continue Caldolor therapy for up to 24 hours. Three hundred patients from 21 clinical sites were enrolled in this study. The shortened infusion time was well tolerated.
Another poster presentation, entitled "A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery" will be on Monday, October 14th, at 10:00 a.m. PST.
This third study was conducted at the Ohio State University Medical Center. The study enrolled fifty-one patients and the results indicate, compared to patients receiving ketorolac, patients receiving intravenous ibuprofen experienced less postoperative pain prior to discharge. Patients receiving Caldolor also needed fewer narcotics and were less likely to require narcotics prior to discharge. This data supports the benefits of using Caldolor in a pre-emptive model of multimodal analgesia
The American Society of Anesthesiologists is an educational research and scientific association of physicians organized to raise and maintain the standards of the medical practice of anesthesiology and improve the care of the patient. Since its founding in 1905, the Society's achievements have made it an important voice in American Medicine and the foremost advocate for all patients who require anesthesia or relief from pain. For more Information, please visit www.asahq.com.
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's marketed products include Acetadote® (acetylcysteine) Injection for the treatment of acetaminophen poisoning, Caldolor® (ibuprofen) Injection, the first injectable treatment for pain and fever approved in the United States, and Kristalose® (lactulose) for Oral Solution, a prescription laxative. Cumberland is dedicated to providing innovative products which improve quality of care for patients. For more information, visit the Company's website at www.cumberlandpharma.com.
SOURCE Cumberland Pharmaceuticals Inc.