Orexo AB announced its wholly owned US subsidiary, Orexo US, Inc., has been awarded USD 8 million in funding by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response in the US 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 USD 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. OX390 is 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 USD 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. There is a crucial need for new treatment options that can complement opioid antagonists for the increasing number of patients exposed to adulteration of illicitly manufactured opioids. We look forward to continuing our collective efforts to develop medical countermeasures as the American opioid epidemic continues to evolve and expose the public in the US to new lethal adulterations of opioids,” said Nikolaj Sørensen, president and CEO of Orexo AB.
“This BARDA funding is an important step in addressing the rapidly evolving adulteration of illicitly manufactured opioids that is challenging US emergency responders and volunteers,” added Edward Kim, MD, MBA, chief medical officer of Orexo US, Inc. “As the science struggles to catch up to the problem, we are seeking a solution driven by our ongoing dialogue with scientists, front line clinicians, and first responders.”
This project has been funded in whole or in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50125C00010.
