Orexo announced that it has resubmitted an NDA for OX124 naloxone nasal powder for the reversal of opioid overdose. In February 2023, the company announced that it had submitted an NDA for OX124 and then in April announced that it would have to resubmit the application due to “unexpected technical issues with the equipment used for the secondary packaging process in the outsourced supply chain for OX124.”
Now, according to Orexo, “The technical issues with the packaging process, which earlier this year gave rise to FDA’s request for filing a new NDA, have now been solved in partnership with the contract manufacturer.” The company says that it expects the review to be completed within 10-13 months and that it anticipates a launch of the product in the US toward the end of 2024 or the beginning of 2025.
Orexo President and CEO Nikolaj Sørensen commented, “Thanks to an excellent team effort, our supply chain for OX124 now meets the highest reliability standards, and we can timely submit a new NDA to the FDA. With the submission of OX124 we are making good progress in expanding our commercial product portfolio in the US and this high-dose life-saving medication has the potential to curb the huge upturn in lethal overdoses seen over the past years and which is grounded in the wide spread of fentanyl. Me and my team look forward to giving broad access to this important and differentiated medication.”
Read the Orexo press release.
