FDA Sets Review for Nasal Opioid Rescue Drug

The FDA has accepted the new drug application and assigned a Prescription Drug User Fee Act date (PDUFA) of July 15, 2024, for Orexo’s OX124. The product is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo´s drug delivery platform, amorphOX.

AmorphOX is a powder-based technology that provides rapid absorption and high bioavailability of naloxone.

Drug overdose continues to be a major public health issue in the United States. From 2020 to 2021, opioid deaths rose 15%, according to CDC. More than 75% of the drug overdose deaths in 2021 involved an opioid.

Nikolaj Sørensen

“OX124 has the potential to reduce the acceleration in fatal overdoses caused by the widespread misuse of synthetic opioids, Nikolaj Sørensen, president and CEO of Orexo said in a press release. “With approval, we intend to initiate commercial activities during the second half of 2024 with a focus on obtaining reimbursement ahead of a broader launch into retail pharmacies early in 2025.”

The submission is supported by data from a pivotal study in healthy volunteers, where OX124 showed a significantly faster and higher absorption of naloxone compared with intramuscular dosing with an injection reference product. In addition, development formulations of OX124 have in a previous exploratory clinical study 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.