In a change of plans, Nek­tar spins out its opi­oid in­to a new biotech sub­sidiary as FDA PDU­FA date looms

Nek­tar Ther­a­peu­tics is spin­ning off a new biotech com­pa­ny and gift­ing it with their late-stage pain drug NK­TR-181 just three months ahead of a re­vised PDU­FA date. And they’ve re­cruit­ed a for­mer Mer­ck ex­ec to take the lead — mark­ing a big shift from the li­cens­ing deal they had con­fi­dent­ly been pro­ject­ing.

Nek­tar $NK­TR has heav­i­ly tout­ed the drug as the first opi­oid that will be free of the im­me­di­ate eu­phor­ic side ef­fects that have trig­gered an epi­dem­ic of abuse around the coun­try. It’s been test­ed in thou­sands of pa­tients with low­er back pain or non-can­cer pain. In­ves­ti­ga­tors for Nek­tar say that the drug is quick­ly ex­pelled — al­low­ing for twice-dai­ly dos­ing — and has a hard time mak­ing it through the blood-brain bar­ri­er, to lim­it the ad­dic­tive side ef­fects.

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