Orexo has announced results from a PK study of its OX124 naloxone nasal spray in 20 healthy volunteers that compared 4 development formulations of OX124 to Narcan naloxone nasal spray. According to the company, all 4 formulations of OX124 demonstrated “substantially higher” plasma concentrations of naloxone compared to Narcan, with equal or faster onset times.
The company, which is also developing OX125 nalmefene nasal spray for the treatment of opioid overdose, said that it plans to conduct a PK bridging study of OX124 after optimizing the formulation and consulting with the FDA. NDA submissions are expected for OX124 in 20121 and for OX125 in 2022.
Orexo President and CEO Nikolaj Sørensen said, “OX124 forms part of our important work to tackle the opioid crisis in the US, and I am very encouraged by the positive results generated by our R&D team. We look forward to advancing OX124 and OX125 and remain confident that we will be able to develop a product for opioid overdose reversal, in line with our strategy to expand our US commercial footprint.”
VP and Head of R&D Robert Rönn added, “We are very pleased with the positive results from the PK study which demonstrate OX124’s potential to improve the ability to reverse the effect of the most powerful synthetic opioids. The results also pave the way for Orexo to develop a new technology platform that shows great promise for further product development.”
Read the Orexo press release.
