FDA's Opioid Trials: Design Debates and Resistance

The FDA's Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) is discussing the best way to set up a clinical trial for opioid candidates to determine efficacy. The proposed clinical trial, called 3033-11, is a post-marketing requirement that the FDA had imposed on companies that have filed NDAs for extended-release or long-acting opioids to treat chronic pain. The committee is debating the clinical trial designs for opioid post-marketing trials to ensure drug safety.