Orexo has filed for FDA approval of a nasal high-dose naloxone formulation based on its amorphOX drug delivery technology, putting it on track to bring the opioid overdose rescue formulation to market in the first half of 2024.
The Swedish drug developer expects the opioid overdose market to split in two, with low-dose products becoming widely available over the counter and high-dose formulations dominating the prescription market. Orexo envisages its nasal naloxone formulation, OX124, competing for a high-dose market that will be driven by a need for potent and longer-lasting overdose rescue medications.
To unlock that opportunity, Orexo has applied its amorphOX delivery technology to naloxone, the active ingredient in Emergent BioSolutions’ approved rescue medication Narcan. The powder-based technology consists of particles built from the drug and carrier materials. By presenting particles as an amorphous composite, Orexo aims to improve chemical and physical stability.
Orexo is seeking approval on the strength of data from a pivotal study in healthy volunteers, which found OX124 provided a significantly faster and higher absorption of naloxone than intramuscular dosing with an injection reference product. An earlier exploratory study linked OX124 to more rapid absorption and higher bioavailability than Narcan. OX124 is protected by patents until 2039.
“With the filing of OX124 we are now one step closer to bringing this important product to market, providing this life-saving medication to the stigmatized and underserved patient group with opioid use disorder. From a business perspective this medication is a great strategic fit, further expanding our portfolio for patients with opioid use disorder,” Orexo CEO Nikolaj Sørensen said in a statement.
Orexo expects the market to grow from the current $300 million to $500 million range as the availability of naloxone products such as OX124 increases.