FDA's pain ad­comm de­bates clin­i­cal tri­al de­signs for opi­oid post-mar­ket­ing tri­als

Now more than six hours in, an FDA ad­comm is still dis­cussing the best way to set up a clin­i­cal tri­al for opi­oid can­di­dates to de­ter­mine ef­fi­ca­cy.

The Anes­thet­ic and Anal­gesic Drug Prod­ucts Ad­vi­so­ry Com­mit­tee (AAD­PAC) met Wednes­day to dis­cuss a pro­posed clin­i­cal tri­al called 3033-11, a post-mar­ket­ing re­quire­ment FDA had im­posed on com­pa­nies that have filed NDAs for ex­tend­ed-re­lease or long-act­ing opi­oids to treat chron­ic pain.

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