NDA submitted to FDA for OX 124, a high-dose rescue medication for opioid overdose

The submission is supported by data from the pivotal study in healthy volunteers, OX124-002, where OX 124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. In addition, development formulations of OX 124 have in a previous exploratory clinical study (OX124-001) in healthy volunteers, demonstrated a more rapid absorption and higher bioavailability compared with the market leading naloxone rescue medication, even with the same dose as the comparator. OX 124 is protected by patents until 2039.

If approved OX 124 will meet the significant and growing need of more powerful rescue medications improving the possibility to revive individuals who have got an overdose caused by use of synthetic opioids, such as fentanyl. During the latest 12-month period, ending April 2023, the predicted annual number of fatal overdoses in the US counted for more than 110.000.The great majority, 76 percent, refers to opioid overdoses, and of these 91 percent involved synthetic opioids.

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. To ensure the manufacturing process meets the highest reliability requirements, tests, and qualifications have successfully been conducted at the contract manufacturers site.

FDA´s review process is expected to take ten to thirteen months. Orexo is planning to initiate the US launch late in H2 2024 or early 2025.