Orexo AB (publ.) announced the expected US launch of OX124, a high-dose rescue medication for opioid overdose, is delayed to late 2024 from previously first half of 2024, if approved by the US Food and Drug Administration (FDA) according to their ordinary timelines. The updated timeline follows unexpected technical issues with the equipment used for the secondary packaging process in the outsourced supply chain for OX124 and there is a need for qualification and documentation of the packaging process to meet the reliability requirements. As a result, FDA has requested Orexo to resubmit a New Drug Application (NDA), when Orexo has completed the qualification and can confirm the packaging process is ready for FDA inspection. The request for a resubmission is solely based on the technical issues in the packaging process and no other concerns have been shared by the FDA.

Orexo expects to resubmit the file during third quarter 2023 with approval expected second half of 2024.