REMS For Individual Opioids Show FDA Flexibility, Keep Class Options Open
Executive Summary
As FDA works with stakeholders on a class-wide Risk Evaluation and Mitigation Strategy for long-acting and extended-release opioids, the REMS that have been approved for individual opioid products indicate agency flexibility in addressing risk management, according to Edgar Adams, executive director of epidemiology at Covance
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The “complete response” letter for the crush-resistant formulation of Endo Pharmaceuticals’ chronic pain drug Opana ER (oxymorphone) is not surprising, given that FDA has yet to settle on a risk management approach for extended-release opioids.