FDA Accepts Orexo's NDA for Opioid Overdose Rescue Medication

Swedish pharmaceutical company Orexo AB (publ.) announces that the US Food and Drug Administration (FDA) have approved a New Drug Application (NDA) for OX124. OX124 is a nasal opioid overdose rescue drug containing high-dose naloxone and is the first product based on Orexo's world-class drug delivery platform, amorphOX.

The PDUFA date is set for July 15, 2024, but recent class review processes indicate the risk of a delay. OX124 addresses the growing need for more effective medications to improve resuscitation options for synthetic opioid overdoses, such as fentanyl, which account for 91 percent of all opioid overdose deaths today.

OX124 is a powerful drug that, along with its rapid absorption and high bioavailability, makes it capable of overdosing or maintaining consciousness in a patient using synthetic opioids. AmorphOX is an innovative powder-based technology that, in addition to rapid absorption and high bioavailability, improves stability and reduces sensitivity to temperature changes.

For users and ordinary people, OX124 can become an effective and reliable rescue drug that does not depend on temperature fluctuations during storage, for example, its effectiveness is not affected by freezing temperatures. OX124 is protected by patents until 2039.

The FDA recently approved low-dose medications that increase the availability of over-the-counter (OTC) medications for overdoses, including the market leader. Historically, OTC products in the United States have received limited reimbursement from insurance companies, and in the future, this may give an advantage to high-dose prescription naloxone products such as OX124, along with similar industrial counterparts.

In addition, high-dose prescription drug providers are expected to benefit from the continued expansion of mandatory co-prescription of naloxone when prescribing opioids to at-risk populations experiencing pain.