Key Caldolor(R) Orthopedic Data to Be Presented at American Academy of Orthopaedic Surgeons' Annual Meeting

Dosed pre- and post-operatively, product met endpoints of reducing pain and morphine use in post-surgical orthopedic patients

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Cumberland Pharmaceuticals Inc.

Mar 04, 2010, 01:02 ET

NASHVILLE, Tenn., March 4 /PRNewswire-FirstCall/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced that results from a clinical trial of Caldolor® (ibuprofen) Injection will be presented at the 2010 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) in New Orleans, Louisiana.

A poster presentation of the study, entitled "A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Ibuprofen Injection (IVIb) for Treatment of Pain in Post-Operative Orthopedic Adult Patients," will be presented daily March 10 – 12 from 12:00 p.m. to 1:00 p.m. Neil Singla, M.D., Chief Executive Officer of Lotus Clinical Research, Inc., is the principal investigator of the study and Byron Kaelin, BSHS, RN, Manager of Clinical Operations at Cumberland Pharmaceuticals Inc., is the presenting author.

The data from this study demonstrates that pre- and post-operative administration of Caldolor is effective in treating pain and reducing morphine utilization in adult patients undergoing orthopedic surgery. No significant differences in adverse events were seen between Caldolor and placebo, including any that would suggest renal, cardiac or bleeding complications. Caldolor is the first and only injectable product approved in the United States to treat pain and fever.

Concurrent with the presentation, the poster will be available on Cumberland Pharmaceuticals' website at http://investor.shareholder.com/cpix/events.cfm. Copies also can be obtained by contacting the Company at 615-255-0068.

The AAOS Annual Meeting is the world's largest meeting of orthopaedic surgeons and allied health professionals and serves as a forum for sharing the latest information on orthopaedic treatments, advances and research. For more information, visit www.aaos.org.

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'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 approved 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.

SOURCE Cumberland Pharmaceuticals Inc.