For a second time, the FDA has turned away Orexo’s nasal spray treatment for opioid overdoses.
The company will need to complete another “human factor” study before resubmitting its application, Orexo said Tuesday in a press release, and that entails making sure individuals can reliably and correctly use a drug-device product. Orexo said it received feedback about the potential need for a new study in April, and it has already been completed.
However, the FDA also requested additional technical data on the final product, a request that Orexo described as “unexpected.” The company said it will “work expeditiously in consultation with the FDA to address this to enable a resubmission of the NDA to FDA as soon as possible.”
The drug, OX124, was attempting to become the latest nasal spray option for people during an overdose, including from fentanyl. OX124’s PDUFA date was July 15.
If it’s eventually approved, Orexo’s drug will be part of the growing overdose rescue market as the opioid epidemic continues to sweep through the US and fentanyl overdoses increase. According to the CDC, there were more than 107,000 drug overdoses last year, about 81,000 of which were due to opioids.
Opioid overdoses decreased last year from about 84,000 in 2022, marking the first time since 2018 that the number of overdoses dropped. However, they are still up significantly since the start of the Covid-19 pandemic. The CDC estimated about 50,000 opioid overdose deaths in 2019.
Regulators last year approved over-the-counter Narcan, a product sold by Emergent BioSolutions, which received a unanimous adcomm vote; and RiVive, another OTC nasal spray version of naloxone hydrochloride.
Indivior’s Opvee was also approved in May 2023, though it’s only available with a prescription. Indivior acquired the drug in its buyout of Opiant Pharmaceuticals in 2022.
Orexo said it doesn’t need to run additional clinical trials. In a trial with healthy volunteers, Orexo said its product induced “significantly faster and higher absorption” than the injectable formulation of naloxone, according to a press release.
Orexo also received a complete response letter in April of last year due to “unexpected technical issues” stemming from the drug’s packaging process, the company said at the time.