Orexo announced that the US Biomedical Advanced Research and Development Authority (BARDA) has awarded the company $8 million to support the development of OX390, a new chemical entity formulated for nasal delivery for the reversal of opioid overdose. According to Orexo, BARDA could potentially provide up to $50.9 million total for the project, in 5 stages, through to regulatory filing. Orexo will retain all rights to OX390, the company said.
In July 2024, the FDA issued a CRL to Orexo’s NDA for OX124 intranasal dry powder naloxone for the reversal of opioid overdose. The company’s pipeline also includes OX125 intranasal nalmefene for the reversal of opioid overdose. In addition to the products for opioid overdose, Orexo is developing OX640 OX640 intranasal dry powder epinephrine and is collaborating with Abera on intranasal dry powder vaccines. In April 2025, the company announced preclinical results for a dry powder nasal flu vaccine.
Orexo President and CEO Nikolaj Sørensen commented, “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.“
Orexo US Chief Medical Officer Edward Kim said, “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. 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.”
Read the Orexo press release
