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Ibuprofen Compares Favorably to Acetaminophen in Newly Published Meta-Analysis

April 13, 2010

NASHVILLE, Tenn., April 13 /PRNewswire-FirstCall/ — Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) today announced results from a meta-analysis comparing the efficacy and safety of ibuprofen and acetaminophen, which was published in the March edition of the peer-reviewed journal The Annals of Pharmacotherapy. The publication notes that in a majority of evaluated studies ibuprofen demonstrated superior efficacy compared to acetaminophen for the treatment of pain and fever, and found no significant safety differences between the drugs.

The data supports findings from several previously published studies on the effectiveness of Caldolor® (ibuprofen) Injection for the treatment of pain and fever. Designed for use in the hospital setting, Caldolor was approved by the U.S. Food and Drug Administration (FDA) and launched by Cumberland in the United States in 2009. Caldolor is the first and only U.S.-approved injectable fever treatment and has been shown to significantly reduce both pain and morphine use in the treatment of pain in adults.

“With the safety of acetaminophen coming under scrutiny recently at an FDA advisory panel meeting, we are pleased that this new data supports the safety and efficacy of ibuprofen as an analgesic and antipyretic,” said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. “This study supports our belief that Caldolor is a valuable option for physicians in the treatment of pain and fever in adults.”

The new publication examined 85 published studies that directly compared oral ibuprofen to oral acetaminophen in the areas of analgesic efficacy, antipyretic efficacy and safety in both adult and pediatric populations. Qualitative review revealed that a majority of the studies concluded ibuprofen is more efficacious than acetaminophen for the treatment of pain and fever in adult and pediatric populations. Meta-analyses on a subset of qualifying studies confirmed these findings and also showed no significant differences in adverse event incidence.

The study, entitled “Efficacy and Safety of Ibuprofen and Acetaminophen in Children and Adults: A Meta-Analysis and Qualitative Review,” was authored by Catherine A. Pierce, PharmD, Pharmaceutical Care Coordinator – Critical Care at Wake Forest University Baptist Medical Center, and Bryan Voss, PhD, formerly with the Department of Pharmacology at the Vanderbilt University School of Medicine and Research Associate at Cumberland Pharmaceuticals. The publication can be found online at www.theannals.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.

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. For more information on Cumberland Pharmaceuticals, please visit www.cumberlandpharma.com.

About The Annals of Pharmacotherapy

Now in its 43rd year, The Annals is an independent, peer-reviewed medical journal that advances pharmacotherapy throughout the world by publishing evidence-based articles on practice and research. The Annals provides an independent forum for the discussion and analysis of professional issues in pharmacotherapy. The Annals publishes research reports, reviews, commentaries, case reports, and other articles that will advance patient care and clinical pharmacy practice.

Important Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that reflect Cumberland’s current views with respect to future events, based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. As with any business, all phases of operations are subject to influences outside of the Company’s control. Risk factors that could materially affect results of operations include, among others, those factors discussed in Cumberland’s Annual Report on Form 10-K as filed with the SEC on March 19, 2010. There can be no assurance that results or developments anticipated by Cumberland will be realized or, if realized, that they will have the expected effects. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Cumberland undertakes no obligation to release publicly any revisions to these statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

SOURCE Cumberland Pharmaceuticals Inc.


Source: newswire



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