16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding the new drug application for OX124, a high-dose naloxone rescue medication in development for opioid overdose. 

The new drug application was submitted to the FDA on 18 September 2023. The complete response letter indicates the need for an additional human factors study, which is in line with previous communication. Furthermore, additional technical data on the final commercial product has been requested. The complete response letter does not indicate a need for additional clinical or non-clinical studies.

Read Orexo press release