Endo Pharmaceuticals Inc., a market leader in pain management has launched three New Dosage Strengths of OPANA(R) ER, an intermediate Strengths Provide Additional Dosing Options for Physicians Treating Patients with Moderate-to-Severe Chronic Pain
The U.S. Food and Drug Administration has approved three new dosage strengths of OPANA® ER (oxymorphone HCl) extended-release tablets CII of Endo Pharmaceuticals Inc. 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.
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.