Nek­tar aban­dons opi­oid drug af­ter a unan­i­mous 27-0 re­buff from FDA ad­comm

Nek­tar had the wrong drug at the wrong time.

That was the im­pli­ca­tion from the FDA staff, who in brief­ing doc­u­ments about Nek­tar’s oral opi­oid painkiller not­ed both the de­clin­ing use of opi­oids na­tion­wide and raised con­cerns about the ef­fec­tive­ness of Nek­tar’s ver­sion, called NK­TR-181.

And it ap­pears the FDA’s ad­vi­so­ry com­mit­tee has come to a sim­i­lar con­clu­sion. The pan­el vot­ed 27-0 against ap­prov­ing the drug, cit­ing con­cerns that pa­tients could abuse it. (The FDA is not oblig­ed to take the ad­vi­so­ry com­mit­tee’s rec­om­men­da­tion, al­though it gen­er­al­ly does.)

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