Brief: Xspray Pharma Says First Study With HyNap-Dasa Does Not Fulfil Requirements

Xspray Pharma publ AB

13/08/2020 08:21

Aug 13 (Reuters) - Xspray Pharma AB (publ)  XSPRAY.ST :
    * SAID ON WEDNESDAY IT ANNOUNCED PRELIMINARY DATA FROM THE
FIRST
OUT OF TWO BIOEQUIVALENCE STUDIES IN HEALTHY VOLUNTEERS WITH ITS
LEAD PRODUCT CANDIDATE HYNAP-DASA
    * PRIMARY AIM WAS TO DEMONSTRATE BIOEQUIVALENCE FOR
HYNAP-DASA
COMPARED TO THE REFERENCE PRODUCT SPRYCEL
    * FIRST STUDY DID NOT FULFIL STATISTICAL BIOEQUIVALENCE
REQUIREMENTS DUE TO HIGH VARIABILITY IN PHARMACOKINETIC
PARAMETERS FOR THE REFERENCE PRODUCT SPRYCEL
    * A FEW SUBJECTS HAD VERY LOW ABSORPTION FROM SPRYCEL WHICH
WAS
NOT OBSERVED FOR HYNAP-DASA
    * AS THESE DATA WITH NEGLIGIBLE ABSORPTION FROM SPRYCEL DO
NOT
REPRESENT A CLINICALLY RELEVANT TREATMENT DRUG EXPOSURE, XSPRAY
INTENDS TO DISCUSS THE RESULTS WITH THE FDA BEFORE SUBMITTING
THE ANDA APPLICATION
    * FINAL RESULTS FROM FULL DATA ANALYSIS ARE EXPECTED IN
SEPTEMBER

    
    
 Source text for Eikon:  urn:newsml:reuters.com:*:nMFNbbCl2N
    
 Further company coverage:  XSPRAY.ST 
   


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