Orexo’s nasal spray satisfied in test, turns to FDA for consultation

Orexo AB’s nasal spray formulations for opioid overdose reversal has been compared to Narcan in a study, in which it showed similar or better results, the company said in a press release on Monday.

The pharmaceutical company addressing opioid addiction and pain, revealed positive results from the human pharmacokinetic (PK) study OX124-001 in 20 healthy volunteers. 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.

The Swedish company said 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.

The results of OX124 encourage Orexo to push the development of its rescue medication capable of reversing any overdose, regardless of which type of opioid has caused it. It’s next step is consultation with the FDA.

Furthermore, this enables Orexo’s Company’s second differentiated rescue drug candidate, OX125, which contains the active substance nalmefene. Orexo hopes to file OX124 and OX125 with FDA in 2021 and 2022.

According to Orexo’s own estimates, greater levels of co-prescriptions and expanding access for opioid dependent patients may increase the market size from today’s $300-500 million to $1.5-2 billion.

Nikolaj Sørensen, President and CEO, Orexo AB, 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.”

“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,” added Robert Rönn, VP and Head of R&D.