Brief: Avenue Therapeutics Receives Complete Response Letter From The FDA For IV Tramadol

Avenue Therapeutics

14/06/2021 14:51

June 14 (Reuters) - Avenue Therapeutics Inc  ATXI.O :
    * AVENUE THERAPEUTICS RECEIVES COMPLETE RESPONSE LETTER FROM
THE
FDA FOR IV TRAMADOL
    * AVENUE THERAPEUTICS INC - FDA DID NOT IDENTIFY ANY
CHEMISTRY,
MANUFACTURING AND CONTROLS ISSUES IN THIS CRL
    * AVENUE THERAPEUTICS - DISAGREES WITH FDA'S INTERPRETATION
OF
DATA IN NDA AND INTENDS TO CONTINUE TO PURSUE REGULATORY
APPROVAL FOR IV TRAMADOL
    * AVENUE THERAPEUTICS - CRL STATED DELAYED, UNPREDICTABLE
ONSET OF
ANALGESIA WITH IV TRAMADOL DOES NOT SUPPORT BENEFIT AS
MONOTHERAPY TO TREAT PATIENTS IN ACUTE PAIN
    * AVENUE THERAPEUTICS - CRL STATED THERE IS INSUFFICIENT
INFO TO
SUPPORT IV TRAMADOL WITH OTHER ANALGESICS IS SAFE, EFFECTIVE FOR
INTENDED PATIENT POPULATION

Source text for Eikon:  ID:nGNX1fj6R 
Further company coverage:  ATXI.O 

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