An­oth­er opi­oid pain drug, re­al­ly? FDA staff sound sour on Nek­tar anal­gesic

The cri­sis of opi­oid abuse, mis­use, and over­dose in the Unit­ed States has made the FDA a tough crit­ic of any opi­oid painkiller up for re­view. Nek­tar’s anal­gesic, NK­TR-181, is no ex­cep­tion.

The drug is a re­duced form of the wide­ly-abused oxy­codone — it is for­mu­lat­ed in a way that in­creas­es the half-life and di­min­ish­es the rate of en­try in­to the brain, ac­cord­ing to Nek­tar, which be­lieves that NK­TR-181’s 16 times slow­er en­try in­to the brain ver­sus oxy­codone will help de­ter abuse — but in brief­ing doc­u­ments post­ed on Fri­day, FDA staff did not sound con­vinced, high­light­ing that the for­mu­la­tion is not en­gi­neered to fa­cil­i­tate abuse de­ter­rence from phys­i­cal ma­nip­u­la­tion.

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