Swedish pharmaceutical company Orexo AB (STO:ORX) (OTCQX:ORXOY) announced on Tuesday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) filing for OX124, a high-dose rescue medication designed to counteract the effects of potent synthetic opioids, including fentanyl.

The Prescription Drug User Fee Act (PDUFA) date is scheduled for 15 July 2024, with a potential risk of slight delays based on recent review processes in the category.

OX124, based on Orexo's drug delivery platform, amorphOX, holds promise in addressing the critical issue of opioid overdoses, particularly those caused by synthetic opioids which account for 91% of all fatal cases in the United States. The medication, characterised by a high dose of naloxone, features rapid absorption and high bioavailability, offering an effective solution for reviving individuals experiencing opioid-induced overdoses. The innovative powder-based technology of amorphOX enhances stability and reduces sensitivity to temperature changes, ensuring efficacy even at freezing temperatures.

OX124 is safeguarded by patents until 2039.

With the demand for overdose medications rising, low-dose products, including the market leader, have recently been approved by the FDA as non-prescription over-the-counter (OTC) products. Orexo noted that, historically, OTC products in the US have had limited reimbursement from insurance companies and, when applying similar industry analogues going forward, this may provide an advantage to high-dose prescription naloxone products, such as OX124. In addition, high-dose prescription products are expected to benefit from the continued expansion of mandatory co-prescription of naloxone when prescribing opioids to at-risk patients suffering from pain.