Pharma Focus Europe

Orexo Submits New Drug Application to FDA for High-Dose Medication OX124 to Counter Opioid Overdose

Monday, September 18, 2023

Orexo AB (publ.), which is publicly traded on the Stockholm Stock Exchange under the symbol STO: ORX and on the OTCQX as ORXOY, has officially submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for OX124. This medication, OX124, is a high-dosage nasal product created to counteract opioid overdoses, with a particular focus on combating potent synthetic opioids such as fentanyl. This development relies on Orexo's advanced drug delivery platform, known as amorphOX®.

The submission of this NDA is backed by data from the pivotal study known as OX124-002, which involved healthy volunteers. In this study, OX124 demonstrated significantly faster and more effective absorption of naloxone compared to intramuscular injection using a reference product. Additionally, previous exploratory clinical research (OX124-001) involving healthy volunteers revealed that various formulations of OX124 exhibited quicker absorption and higher bioavailability compared to the leading naloxone rescue medication on the market, even when using equivalent doses. Orexo holds patent protection for OX124 until 2039.

If approved, OX124 aims to meet the increasing demand for more potent rescue medications, offering improved chances of reviving individuals experiencing opioid overdoses, especially those caused by synthetic opioids like fentanyl. Over the 12 months leading up to April 2023, it is estimated that there were over 110,000 fatal overdoses in the United States. A significant majority, accounting for 76%, were attributed to opioid overdoses, with 91% of these cases involving synthetic opioids.

The technical challenges encountered in the packaging process, which led to the FDA's request for a new NDA earlier this year, have been successfully resolved in collaboration with the contract manufacturer. Stringent testing and qualifications have been conducted at the contract manufacturer's facility to ensure that the manufacturing process meets the highest reliability standards.

Nikolaj Sørensen, President and CEO of Orexo AB, expressed his satisfaction with the progress made, stating, "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."

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

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