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FDA Approves Three New Dosage Strengths of Oxymorphone HCl Extended Release CHADDS FORD, Pa -- March 3, 2008 -- The US Food and Drug Administration has approved three new dosage strengths of oxymorphone HCl (Opana) extended-release (ER) tablets CII. The new strengths -- 7.5 mg, 15 mg, and 30 mg -- will be available on April 1, 2008, and will join previously approved oxymorphone HCl ER dosage strengths of 5 mg, 10 mg, 20 mg, and 40 mg. An opioid analgesic, oxymorphone HCl ER is indicated for the relief of moderate-to-severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time. The approval is based on studies demonstrating the safety and efficacy of oxymorphone HCl ER in its four original strengths. Because the new dosages fall between the available strengths, FDA did not require new safety or efficacy studies. Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxymorphone HCl ER in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Oxymorphone HCl tables are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or crushed tablets leads to rapid release and absorption of a potentially fatal dose of oxymorphone. Oxymorphone HCl ER is not indicated for pain in the immediate post-operative period (12-24 hours following surgery), or if pain is mild or not expected to persist for an extended period of time. Respiratory depression is the chief hazard of oxymorphone HCl ER, particularly in elderly or debilitated patients. The most common adverse drug reactions (>= 10%) in all clinical trials for oxymorphone HCl ER were nausea, constipation, dizziness (excluding vertigo), vomiting, pruritus, somnolence, headache, increased sweating, and sedation. SOURCE: Endo Pharmaceuticals Inc. E-mail this page to a friend or colleague! To print, use this version