Orexo Shares New Timeline for the High-Dose Rescue Medication for Opioid Overdose, OX124

Orexo today announces 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 Q3 2023 with approval expected second half of 2024

Nikolaj Sørensen, President and CEO of Orexo AB, said: “As a lifesaving rescue medication OX124 must meet the highest standard of reliability and quality in the manufacturing process. This requires Orexo and our manufacturing partners to scrutinize all aspects of the value chain and any potential issues are assessed in detail before initiating commercial manufacturing. I am disappointed with the delay in the process of bringing this life saving medication to the US market. However, I am pleased the manufacturing team is confident we have a solution to the technical issues in the packaging process and that it has no impact on the chances for final approval. When solved, this will even further strengthen the supply chain for our future rescue medications, such as OX640 and OX125.”