NDA submitted to FDA for OX 124 a high-dose rescue medication for opioid overdose.- Orexo AB
Orexo AB (publ.), announces the submission of a New Drug Application (NDA) to the FDA for its lead pharmaceutical pipeline asset, OX 124, a nasal rescue medication for opioid overdose.
OX 124, is based on Orexo´s drug delivery platform amorphOX and contains a high-dose of naloxone. 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. 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 August 2022, the predicted annual number of fatal opioid overdoses in the US exceeded 81,0001. Nine out of ten opioid overdose deaths involved synthetic opioids, including fentanyl. The switch to highly potent synthetic opioids has led to more severe overdoses, prompting the need for high-dose naloxone products.
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 OX 124. The increased availability of naloxone products is expected to grow the market from today’s USD 300-500 million. OX 124 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 recue medication will much likely also benefit the market for prescription products.</p >
FDA´s ordinary review process is 10 months, but recent review processes in the category have been about 13 months. Orexo is planning to initiate the US launch during H1 2024.
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