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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER