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BRIEF-FDA staff: Difficult to assess impact of Opana ER’s reformulation on overall abuse of the drug

March 9 Endo International Plc

* FDA staff: postmarketing data suggests opana er reformulation likely reduced nasal abuse rates, but data limitations makes it hard to determine magnitude of effect

* FDA staff: postmarketing data indicate an increase in opana er injection abuse rates over the study period

* FDA staff: the data are difficult to interpret with regard to the impact of opana er’s reformulation on overall abuse of the drug (via any route). Source text for Eikon: (bit.ly/2m62jla) Further company coverage:

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