FDA Decision Delay On Zohydro ER: No News May Be Good News
This article was originally published in The Pink Sheet Daily
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.
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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.
Supporters of narrowing opioid drugs’ non-cancer pain indication tell FDA that pain patients often suffer the consequences of addiction and misuse.
FDA draft guidance says there is no clear epidemiologic strategy for gathering the data to demonstrate that has reduced abuse; the agency outlines four possible kinds of abuse deterrence claims, three of which can be obtained through pre-market studies.