Orexo ( OTCQX:ORXOY ) said it submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of nasal rescue medication for opioid overdose, OX124.
OX124, is based on Orexo's drug delivery platform amorphOX and contains a high-dose of naloxone, the company added.
The NDA was backed by data from a study, dubbed OX124-002, in healthy people where OX124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product, according to the Swedish company.
Orexo added that in a previous exploratory study called OX124-001 in healthy people, OX124 showed a more rapid absorption and higher bioavailability compared to the market leading naloxone rescue medication, even with the same dose as the comparator.
"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," said Orexo President and CEO Nikolaj Sørensen.
OX124 is designed to reverse the effects of powerful synthetic opioids, such as fentanyl. OX124 is protected by patents until 2039, as per the company.
Orexo is planning to start the U.S. launch of the therapy, if approved, in H1 2024.
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Orexo files for FDA approval of opioid overdose nasal rescue treatment OX124