Orexo AB (publ.) announced the New Drug Application (NDA) for OX124 has been accepted for review by the US Food and Drug Administration (FDA). OX124 is a nasal rescue medication for opioid overdose containing a high dose of naloxone and is the first product based on Orexo's world-classdrug delivery platform, amorphOX. The PDUFA date is set to July 15, 2024, but recent review processes in the category indicate a risk of some delay.

OX124 will meet the growing need for more powerful medications to improve the possibility of reviving individuals experiencing an overdose caused by use of synthetic opioids, such as fentanyl, which cause 91% of all fatal opioid overdoses. OX124 is a potent medication and, in combination with rapid absorption and high bioavailability, this makes it capable of reversing an overdose or sustaining consciousness in a patient who has taken synthetic opioids. A MorphOX is an innovative powder-based technology that, in addition to rapid absorption and high bioavailability., improves stability and reduces sensitivity related to temperature changes.

For users and lay-people OX124 has the potential to become an efficient and reliable rescue medication independent of temperature variations during storage, for example its efficacy is not affected at freezing temperatures. OX124 is protected by patents until 2039. Driven by the need to increase access to overdose medication, low-dose products, including the market leader, have recently been approved by the FDA as non-prescription over-the-counter (OTC) products.

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.