Orexo AB (publ) announced positive results from the human pharmacokinetic (PK) study OX124-001 in 20 healthy volunteers, assessing Orexo's novel naloxone nasal spray formulations intended for opioid overdose reversal. The study was a cross-over, comparative, bioavailability study comparing four development formulations of OX124 to Narcan Nasal Spray 4mg, the current market-leading naloxone rescue medication in the US. All formulations of OX124 were well tolerated and showed substantially higher plasma concentrations of naloxone, sustained duration of elevated plasma concentrations, and equivalent or superior onset time when compared to Narcan. Highly potent synthetic opioids such as fentanyl have become the leading cause of death following drug overdoses in the US, with nearly 30,000 fatalities in 2017. Currently available naloxone-based rescue medications struggle to reverse effects of such opioids. Orexo believes that the present results for OX124 will allow for the development of a proprietary rescue medication capable of reversing any overdose, irrespective of which type of opioid has caused it. The next step for OX124 is to continue to further optimize the formulation and prepare for a pivotal pharmacokinetic bridging study in consultation with the US Food and Drug Administration, FDA. The positive study results will also enable Orexo to accelerate development of the Company's second differentiated rescue drug candidate, OX125, which contains the active substance nalmefene. Assuming further successful development, Orexo expects to file OX124 and OX125 with FDA in 2021 and 2022, respectively.