New opi­oid could re­place IV painkillers

The Daily Courier - - LIFE -

TREN­TON, N.J. (AP) — U.S. reg­u­la­tors on Fri­day ap­proved a fast-act­ing, su­per-po­tent opi­oid tablet as an al­ter­na­tive to IV painkillers used in hos­pi­tals.

The de­ci­sion by the Food and Drug Ad­min­is­tra­tion came over ob­jec­tions from crit­ics who fear the pill will be abused. In a lengthy state­ment, FDA Com­mis­sioner Scott Got­tlieb said there will be “very tight re­stric­tions” placed on its dis­tri­bu­tion and it is in­tended only for su­per­vised set­tings like hos­pi­tals.

The tiny pill was de­vel­oped as an op­tion for pa­tients who pose dif­fi­cul­ties for the use of IVs, in­clud­ing sol­diers on the bat­tle­field. The pill from AcelRx Phar­ma­ceu­ti­cals con­tains the same decades-old painkiller of­ten given in IV form or in­jec­tion to sur­gi­cal pa­tients and women in labour.

Got­tlieb noted the pill was a high pri­or­ity for the Depart­ment of De­fence, which helped fund test­ing, be­cause it wanted a way to pro­vide fast pain re­lief to in­jured sol­diers. The tablet, placed un­der the tongue, starts re­duc­ing pain in 15 to 30 min­utes.

A panel of FDA ad­vis­ers had ear­lier voted 10-3 in favour of the pill called Dsu­via). But in a rare re­sponse, the panel’s chair­man joined crit­ics in urg­ing the FDA to re­ject it.

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