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Lauren Vinson |
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MONTGOMERY, AL, March 13, 2008 – MONTGOMERY, AL, March 5, 2008 - ProEthic Pharmaceuticals, Inc. today announced the launch of Ibudone™ (hydrocodone bitartrate and ibuprofen tablets), a new prescription fixed combination of hydrocodone and ibuprofen for the short-term (generally less than 10 days) management of acute pain.
Ibudone provides the highest hydrocodone/ibuprofen dosage available – 10mg of hydrocodone/ 200 mg of ibuprofen – in each tablet. Peak plasma levels are achieved in less than two hours. Ibudone is also available with 5mg hydrocodone/ 200 mg of ibuprofen.
Carl Whatley, Chairman and CEO of ProEthic Pharmaceuticals, stated, “By combining 10mg of hydrocodone with the gold standard NSAID, ibuprofen, Ibudone offers a powerful new option for relieving acute pain. It is important to note that Ibudone does not have the risk of acetaminophen liver toxicity, a leading cause of acute liver failure in the United States. In addition, Ibudone also offers physicians Schedule III prescribing convenience, a key issue with today’s busy practices.”
ProEthic acquired the exclusive marketing, sales and distribution rights to Ibudone from Vintage Pharmaceuticals (Huntsville, Alabama). To learn more about Ibudone, visit www.ibudone.com.
Ibudone (hydrocodone bitartrate and ibuprofen tablets) is indicated for the short-term (generally less than 10 days) management of acute pain. Ibudone tablets are not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis. Ibudone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). Serious gastrointestinal toxicity, such as inflammation, bleeding, ulceration and perforation of the stomach, small intestine, or large intestine, with or without warning symptoms, can occur in patients taking NSAIDs. NSAIDs have been associated with an increase in cardiovascular adverse events. The most commonly reported side effects with Ibudone include headache, nausea, dizziness, dyspepsia, somnolence, and constipation. Hydrocodone may impair mental and/or physical abilities when ingested with alcohol and other CNS depressants. Ibudone tablets should be used with caution in elderly or debilitated patients, and in those patients with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture.
Please see full Prescribing Information for more on Warnings, Precautions and additional Adverse Reactions that may occur.
ProEthic is an emerging specialty pharmaceutical company enhancing treatment strategies initially in the areas of pain and migraine. Founded in 2001, the privately held company focuses its efforts on the acquisition, development, licensing, and marketing of pharmaceutical products. For more information, please visit the ProEthic website at: www.proethic.com.
