Orexo has announced the submission of a New Drug Application to the US Food and Drug Administration for its lead pharmaceutical pipeline asset, OX124, a nasal rescue medication for opioid overdose.
OX124, is based on Orexo’s drug delivery platform amorphOX and contains a high-dose of naloxone.
“With the filing of OX124 we are now one step closer to bringing this important product to market, providing this life-saving medication to the stigmatized and underserved patient group with opioid use disorder. From a business perspective this medication is a great strategic fit, further expanding our portfolio for patients with opioid use disorder, complementing ZUBSOLV and MODIA,” says Nikolaj Sørensen, President and CEO of Orexo.
The submission is supported by data from the 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. FDA’s ordinary review process is 10 months, states the company, but recent review processes in the category have been about 13 months. Orexo is planning to initiate the US launch during H1 2024.
Photo of Nikolaj Sørensen: Jenny Öhman/Nordic Life Science
