Brief: Orexo Announced New Timeline For OX124

Orexo AB

03/04/2023 07:39

April 3 (Reuters) - Orexo AB  ORX.ST :
    * SHARES NEW TIMELINE FOR THE HIGH-DOSE RESCUE MEDICATION FOR OPIOID OVERDOSE, OX124
    * EXPECTED US LAUNCH OF OX124, A HIGH-DOSE RESCUE MEDICATION FOR OPIOID OVERDOSE, IS DELAYED
TO
LATE 2024 FROM PREVIOUSLY FIRST HALF OF 2024
    * UPDATED TIMELINE FOLLOWS UNEXPECTED TECHNICAL ISSUES WITH EQUIPMENT USED FOR SECONDARY
PACKAGING
PROCESS IN OUTSOURCED SUPPLY CHAIN FOR OX124
    * THERE IS A NEED FOR QUALIFICATION AND DOCUMENTATION OF PACKAGING PROCESS TO MEET
RELIABILITY
REQUIREMENTS. AS A RESULT, FDA HAS REQUESTED OREXO TO RESUBMIT A NEW DRUG APPLICATION (NDA)
    * EXPECTS TO RESUBMIT FILE DURING Q3 2023 WITH APPROVAL EXPECTED SECOND HALF OF 2024

Source text for Eikon:  ID:nWkr1cRX1y 
Further company coverage:  ORX.ST 

 (Gdansk Newsroom)
 ((gdansk.newsroom@thomsonreuters.com; +48 58 7696600;))