USA – FDA Lays Out Plan for Comparing New Opioids to Previously Approved Ones

The US Food and Drug Administration (FDA) on Thursday released new draft guidance on its benefit-risk assessment framework for opioids, outlining how the agency plans to compare the effectiveness and safety of new opioids with already approved opioids.

The idea for a comparative approval standard, discussed by former FDA Commissioner Scott Gottlieb in March before a Senate committee, hinges on the fact that “FDA believes that there should be a premarket demonstration that a new opioid is superior to an already-approved opioid,” Gottlieb said.

The new 7-page draft guidance lays out a series of questions that FDA says it will consider in assessing the effectiveness and safety of a new opioid:

  • “Do any comparative efficacy data exist for the drug relative to approved opioid or nonopioid analgesic drugs? Does this analgesic drug offer any advantages relative to available approved analgesic drugs for each indication, with regard to effectiveness or duration of response?
  • Do any comparative safety data exist for the drug relative to approved opioid or nonopioid analgesic drugs? Does this analgesic drug offer any other safety advantages or disadvantages relative to available approved analgesic drugs for each indication (e.g., abuse-deterrent properties, less risk of drug-drug interactions)?
  • What is the anticipated benefit-risk balance relative to available approved analgesic drugs for each indication? Do any comparative safety data exist for the drug relative to approved opioid or nonopioid analgesic drugs? Does this analgesic drug offer any other safety advantages or disadvantages relative to available approved analgesic drugs for each indication (e.g., less risk of drug-drug interactions)?
  • Does the drug have any other advantages over other available approved analgesic 153 drugs (e.g., can be mixed with food)?”…