Orexo Submits Life-Saving Nasal Medication for Opioid Overdose to FDA

News Updates (2)

Orexo AB, a pharmaceutical company, has made a significant move in the fight against opioid overdoses by submitting a New Drug Application (NDA) for its lead pharmaceutical pipeline asset, OX124, to the US Food and Drug Administration (FDA).

Revolutionary Drug Delivery Platform

OX124 is a nasal rescue medication for opioid overdose and is based on Orexo’s innovative drug delivery platform, amorphOX®. The medication contains a high dose of naloxone, which is an opioid antagonist used to treat opioid overdoses.

Fast and Effective Absorption

The submission is backed by data from the pivotal study in healthy volunteers, OX124-002, where OX124 showed significantly faster and higher absorption of naloxone compared to intramuscular dosing with an injection reference product. In a previous exploratory clinical study (OX124-001) in healthy volunteers, OX124 demonstrated a more rapid absorption and higher bioavailability compared to the market-leading naloxone rescue medication, even with the same dose as the comparator.

Growing Need for High-Dose Naloxone Products

Opioid overdoses are a life-threatening condition characterized by loss of consciousness and respiratory depression. During the 12-month period ending August 2022, the predicted annual number of fatal opioid overdoses in the US exceeded 81,000. The switch to highly potent synthetic opioids, including fentanyl, has led to more severe overdoses and a growing need for high-dose naloxone products.

Patented and Protected

OX124 is protected by patents until 2039, making it a valuable asset in the fight against opioid overdoses.

Expanding Portfolio for Opioid Use Disorder

Nikolaj Sørensen, President and CEO of Orexo AB, stated that the submission of OX124 brings the company one step closer to bringing this important product to market and providing this life-saving medication to the underserved patient group with opioid use disorder. OX124 complements Orexo’s existing portfolio for patients with opioid use disorder, ZUBSOLV® and MODIA®.

Growing Market for Naloxone Products

The market for naloxone products is expected to grow from today’s USD 300-500 million and convert into a low-dose over-the-counter (OTC) market and a high-dose prescription market, including OX124. As a high-dose prescription product, OX124 will have access to reimbursement and act in a differentiated market from the OTC market, which is likely to include the current market leader and generics.

Expected Launch in H1 2024

The FDA’s ordinary review process is 10 months, but recent review processes in the category have been about 13 months. Orexo is planning to initiate the US launch of OX124 during H1 2024.

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