Orexo US Awarded $8M in Funding by BARDA 

Orexo AB’s wholly owned U.S. subsidiary, Orexo US Inc., has been awarded $8 million in funding by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response in the U.S. Department of Health and Human Services. The funding will support the development of OX390, an intranasal rescue medication for adulterated opioid overdoses. 

The award is structured in five stages and is valued at up to $50.9 million that could be awarded if specific milestones and deliverables are achieved. It will contribute to the funding for Orexo to perform non-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory filing for a formulation of OX390 suitable for community use. 

OX390 is a New Chemical Entity (NCE) with a novel formulation and route of administration for human use. Itis intended to reverse respiratory depression associated with adulterated illicit opioid overdoses, which is a rapidly increasing problem in the US. OX390 uses Orexo’s proprietary AmorphOX dry-powder drug delivery technology which has been validated in multiple clinical studies with other molecules and has demonstrated rapid and extensive drug exposure. The first stage of the contract provides approximately $8 million to support the completion of the agreed activities. Upon completion of the project and FDA approval of the product, Orexo will retain all commercial rights to OX390. 

“We are excited to initiate our partnership with BARDA in the development of OX390. We aim to develop a rapidly deployable intranasal rescue medication using our proprietary AmorphOX technology for the emergency treatment of respiratory depression associated with adulterated illicit opioids,” said Nikolaj Sørensen, President and CEO of Orexo AB. 

This project has been funded in whole or in part with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50125C00010.