Orexo announces positive results from pivotal trial for its leading pharmaceutical pipeline asset OX 124.

The study met its primary endpoints with naloxone exposure within the targeted interval. OX 124 showed a significantly faster and higher absorption of naloxone compared to intramuscular dosing with the injection reference product. Furthermore, OX 124 was found to be well tolerated.

The use of synthetic opioids is the leading cause of death in fatal overdoses in the US, a trend that has seen further acceleration in the wake of the Covid-19 pandemic. For the twelve-month period leading up to March 2021, the number of reported overdose deaths surpassed 96,000 for the first time in history, an increase of 30 percent versus the previous year. Approximately 75 percent of these deaths were caused by opioids, and within the opioid-related deaths, synthetic opioids accounted for the vast majority, underlining the need for more powerful and faster-acting rescue medications.

Based on the successful outcome of the study, Orexo is expecting to file a New Drug Application with the FDA in H2 2022, when results from the ongoing, required stability study is available. Following FDA approval, a US launch will be initiated in H2 2023.

OX 124 is a powerful high-dose naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl. To meet the target profile for a more potent rescue medication, Orexo has developed a unique and patented powder formulation technology that allows for rapid and efficient delivery of active ingredients through the intranasal route. In a previous exploratory clinical study (OX124-001) in healthy volunteers, OX 124 showed more rapid absorption, substantially higher plasma concentrations of naloxone, and sustained duration of elevated plasma concentrations when compared to the current market leader.