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Three New Dosage Strengths of Oxymorphone HCl Clear FDA Hurdle

March 4, 2008 -- The U.S. Food and Drug Administration has approved three new dosage strengths of OPANA(R) ER (oxymorphone HCl) extended-release 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 OPANA ER dosage strengths of 5 mg, 10 mg, 20 mg, and 40 mg. An opioid analgesic, OPANA 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. (See Important Safety Information below.)

"The addition of three new dosage strengths of OPANA ER, complementing the currently available strengths, will make it easier for physicians to titrate patients to the optimal level of pain relief," said David A. Lee, M.D., Ph.D., Chief Scientific Officer. "The new strengths will also facilitate clinicians' ability to convert patients to OPANA ER from other opioid analgesics to which they may not have had an adequate clinical response. Further, the introduction of these new strengths underscores Endo's long-term commitment to the OPANA franchise and to providing physicians with additional treatment options for their appropriate chronic pain patients."

The approval is based on studies demonstrating the safety and efficacy of OPANA ER in its four original strengths. Because the new dosages fall between the available strengths, FDA did not require new safety or efficacy studies.

Source: Endo Pharmaceuticals About OPANA ER Tablets OPANA ER tablets were formulated using oxymorphone hydrochloride, a semisynthetic, pure u-opioid agonist that had been available previously only as an injectable formulation. The product has been proven to achieve effective relief in multiple moderate-to-severe chronic pain models, in opioid-naive and opioid-experienced patients. All OPANA ER strengths are available by prescription only.

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