Orexo has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for its high-dose rescue medication, OX124, for opioid overdose with nasal delivery.

Leveraging the amorphOX drug delivery platform, OX124 is expected to reverse the effects of synthetic opioids such as fentanyl.

The NDA is supported by results from the OX124-002 pivotal trial in healthy volunteers, where OX124 demonstrated a quicker and higher absorption of naloxone compared with intramuscular dosing with an injection reference product.

Furthermore, in a prior exploratory clinical study (OX124-001) involving healthy volunteers, OX124 development formulations exhibited absorption speed and greater bioavailability when compared with the leading naloxone rescue medication on the market.

The FDA's review is expected to take between ten and 13 months. Orexo intends to begin the US launch in either the latter half of 2024 or early 2025.

If OX124 is approved, it will address the increasing demand for more potent rescue medications.

According to the company, patents safeguard OX124 until 2039.

Orexo president and CEO Nikolaj Sørensen said: “With the submission of OX124 we are making good progress in expanding our commercial product portfolio in the US and this high-dose, life-saving medication has the potential to curb the huge upturn in lethal overdoses seen over the past years and which is grounded in the wide spread of fentanyl.

“Me and my team look forward to giving broad access to this important and differentiated medication.”