Orexo submits New Drug Application to FDA for OX124, a high-dose rescue medication for opioid overdose
Orexo AB has submitted a New Drug Application (NDA) to the FDA for OX124, a nasal rescue medication aimed at reversing opioid overdoses, particularly from synthetic opioids like fentanyl. With opioid overdoses surpassing 81,000 annually in the U.S., the high-dose naloxone formulation of OX124 promises faster and more effective treatment, as demonstrated in pivotal studies. The product is expected to launch in H1 2024, potentially expanding the naloxone market significantly, which is currently valued at USD 300-500 million. OX124 is protected by patents until 2039.
- Submission of NDA for OX124, indicating progress in drug development.
- OX124 demonstrated faster and higher absorption of naloxone compared to traditional methods.
- Patented until 2039, providing a competitive edge.
- Potential to expand the naloxone market significantly, benefitting from rising overdose incidents.
- The FDA review process may take longer than the standard 10 months.
- Dependence on regulatory approval for market access.
- OX124 is designed to reverse the effects of the most powerful synthetic opioids, such as fentanyl
- Nine out of ten fatal opioid overdoses in the US involve synthetic opioids
- If approved, the US launch is expected to be initiated in H1 2024
UPPSALA,
The submission is supported by data from the pivotal study in healthy volunteers, OX124-002, where OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. In addition, development formulations of OX124 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. OX124 is protected by patents until 2039.
Opioid overdose is a life-threatening condition, characterized by loss of consciousness and respiratory depression. Opioid overdoses can be treated with the opioid antagonist naloxone. During the 12-month period ending
The market today is solely based on prescription products but is likely to convert into a low-dose over the counter (OTC) market and a high-dose prescription market, including OX124. The increased availability of naloxone products is expected to grow the market from today's USD 300-500 million. OX124 will, as a high-dose prescription product, have access to reimburse-ment and act in a differentiated market to the OTC market, which is likely to include the current market leader and generics thereof. The large need for potent and longer-lasting overdose rescue medications will most likely propel the prescription market. In addition, the on-going expansion of mandatory co-prescription of naloxone rescue medication will much likely also benefit the market for prescription products.
FDA´s ordinary review process is 10 months, but recent review processes in the category have been about 13 months.
For further information please contact:
Tel: +46 (0)18 780 88 00 | Tel: +46 (0)18 780 88 00 | ||
E-mail: ir@orexo.com | E-mail: ir@orexo.com |
About OX124-002
This pivotal trial was a 4-period cross-over, comparative bioavailability study in healthy volunteers, comparing two dose regimens of OX124 to two dose regimens of an injection reference product. The study met its primary endpoints with naloxone exposure within the targeted interval. In addition, it showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with the injection reference product. OX124 was also well tolerated.
About OX124-001
This study was a cross-over, comparative, bioavailability study comparing four development formulations of OX124 to the market leading naloxone rescue medication (4 mg) in the US. All formulations of OX124 were well tolerated and showed substantially higher plasma concentrations of naloxone, sustained duration of elevated plasma concentrations, and equivalent or superior onset time versus the comparator.
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The information was submitted for publication at 8.00 CET on
1 https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm.
During the same period the predicted annual number of total fatal overdoses amounted to more than 107,000.
The following files are available for download:
https://mb.cision.com/Public/694/3708308/b9ed682c263ad8b2.pdf | Orexo Press Release Orexo submits NDA to FDA for OX124 Published |
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