Mallinck­rodt's woes per­sist as re­for­mu­lat­ed opi­oid painkiller fails to pass FDA muster

The FDA’s re­luc­tance with pre­scrip­tion painkillers at a time the Unit­ed States is swept by a tsuna­mi of opi­oid abuse, over­dose and ad­dic­tion was on full dis­play on Wednes­day, when the reg­u­la­tor re­ject­ed Mallinck­rodt’s $MNK abuse-de­ter­rent opi­oid painkiller, so­lic­it­ing more da­ta from the UK drug­mak­er.

The drug un­der scruti­ny was a tweaked ver­sion of Rox­i­codone, an im­me­di­ate-re­lease for­mu­la­tion of the com­mon­ly abused opi­oid oxy­codone that was ap­proved by the FDA in 2000. This re­for­mu­la­tion was de­signed to de­ter abuse via snort­ing or in­ject­ing. In its CRL, the agency “pro­vid­ed guid­ance re­gard­ing ar­eas of fur­ther eval­u­a­tion nec­es­sary to re­sub­mit the NDA for fur­ther re­view,” Mallinck­rodt said.

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