Opioid Long-Term Effectiveness: FDA Postmarket Trial Design Offers ‘Best Compromise’
FDA advisory committee to consider proposed protocol to meet postmaketing requirement set a decade ago to determine risk of hyperalgesia following long-term use of ER/LA opioid analgesics. Initial trial was terminated in 2018 due to inability to recruit enough patients.
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US FDA Commissioner Califf has proposed that the agency move away from ‘gladiator votes’ that frame advisory committee meetings as a yes-or-no decision on a single question and instead emphasize the importance of the expert discussion and nuance of regulatory issues. The latest high-profile advisory committee review of a key opioid response issue shows the challenges with that approach.
Advisory committee agrees that a proposed study protocol could enroll patients but notes the outcome is foreseeable. Industry representative questions whether this postmarketing requirement is necessary.
New clinical practice guideline recommends immediate-release opioids instead of extended-release and long-acting opioids when starting pain therapy. It specifies high dose is 50 mg morphine equivalent dose (MME) per day or higher. The 2016 guideline had set it at 90 MME/day.