A snakebit biotech re­ceives sec­ond CRL for re­for­mu­lat­ed pain med, po­ten­tial­ly putting the ki­bosh on its chances

Fortress Biotech’s small cap com­pa­ny Av­enue Ther­a­peu­tics has run in­to an­oth­er road­block at the FDA, and this time it may prove to be a TKO.

Av­enue re­ceived its sec­ond CRL for an IV for­mu­la­tion of the drug tra­madol to treat post-op­er­a­tive pain, the biotech an­nounced Mon­day morn­ing, fol­low­ing an ini­tial re­jec­tion last Oc­to­ber. The thumbs down was due to the FDA find­ing the “de­layed and un­pre­dictable on­set” of pain re­duc­tion from tra­madol didn’t sug­gest a ben­e­fit as a monother­a­py, and there’s not enough in­for­ma­tion to know whether it works in com­bi­na­tion with oth­er ther­a­pies, Av­enue said.

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