Brief: Avenue Therapeutics Inc - REACHES FINAL AGREEMENT WITH THE U.S. FDA FOR THE PHASE 3 SAFETY STUDY

Fortress Biotech

04/01/2024 13:44

Jan 4 (Reuters) - Avenue Therapeutics Inc  ATXI.O :
    * AVENUE THERAPEUTICS REACHES FINAL AGREEMENT WITH THE U.S.
FDA
FOR THE PHASE 3 SAFETY STUDY FOR IV TRAMADOL
    * STUDY WILL RANDOMIZE APPROXIMATELY 300 POST BUNIONECTOMY
PATIENTS TO IV TRAMADOL OR IV MORPHINE FOR PAIN RELIEF
    * SAYS STUDY CAN BE COMPLETED WITHIN 12 MONTHS AND SUBMITTED
TO
FDA
    * BELIEVES STUDY CAN BE COMPLETED IN 12 MONTHS & SUBMITTED
TO FDA
TO ADDRESS CRL & POTENTIALLY LEAD TO APPROVAL OF IV TRAMADO

Source text for Eikon:  ID:nGNX7Ql9p1 
Further company coverage:  ATXI.O 

 ((Reuters.Briefs@thomsonreuters.com;))