Orexo has announced that a Phase 1 bioavailability study of three formulations of its OX125 intranasal nalmefene compared to intramuscular nalmefene injection showed that all three were well tolerated and well absorbed. Orexo is developing both the nasal formulation of nalmefene and a nasal formulation of naloxone for the treatment of opioid overdose.
Orexo VP and Head of R&D Robert Rönn said, “I am pleased with the results from this important clinical study as well as the timely delivery from Orexo’s R&D team. This is not only a proof-of-concept for our wholly-owned OX125 product, but also a demonstration of the value of our novel nasal technology platform. We will now set forth to engage with US Food and Drug Administration, FDA, to identify the optimal route to market.”
President and CEO Nikolaj Sørensen commented, “As the US heroin crisis has developed to a fentanyl crisis, the medical need for novel and more powerful opioid rescue medications is vast. The need has also escalated further due to the COVID19 pandemic as the consequences of social distancing and economic weakness are expected to lead to a significant increase in mental health issues and substance use disorders. Alongside OX124, our naloxone rescue project, OX125 will be an important lifesaving addition in our commitment to helping patients suffering from opioid addiction in all phases. I am encouraged by the results from our R&D team and look forward to the continued development of this pharmaceutical product.”
Read the Orexo press release.
