Opioid Abuse-Deterrent Formulations Could Become Prerequisite To Approval
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee recommends against approval of Zogenix’s Zohydro ER as it seeks safer formulations and stricter REMS for all extended-release/long-acting opioids.
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FDA approved Zogenix’ single-entity hydrocodone product following a negative advisory committee meeting, and is facing ongoing opposition as the drug’s launch begins. The agency argues the risk is consistent with other extended-release opioids – and abuse-deterrent technology is too new to require.
Zogenix says the agency expects its review of the hydrocodone-only analgesic to extend beyond its March 1 user fee date, possibly by only several weeks, but has not provided an explanation for the delay.
Supporters of narrowing opioid drugs’ non-cancer pain indication tell FDA that pain patients often suffer the consequences of addiction and misuse.