Re­cro Phar­ma tees up an NDA for its COX-2 pain drug fol­low­ing pos­i­tive PhI­II pro­gram

Lit­tle, Malvern, PA-based Re­cro Phar­ma $REPH post­ed pos­i­tive Phase III da­ta for the IV for­mu­la­tion of their pain ther­a­py meloxi­cam. Shares bumped up 10% on the da­ta.

Af­ter tak­ing a look at safe­ty and tol­er­a­bil­i­ty in the 722-pa­tient study, the com­pa­ny says it has put the last piece in place for the da­ta puz­zle be­ing pre­sent­ed to the FDA for mar­ket­ing ap­proval of the non-opi­oid COX-2 in­hibitor.

Re­cro has been po­si­tion­ing its lead ther­a­py for the post-op­er­a­tive mar­ket, look­ing to break in with a ther­a­py that can avoid the per­ils as­so­ci­at­ed with opi­oid use. An NDA should ar­rive at the FDA in ear­ly Q3, com­pa­ny ex­ecs say.

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