Orexo Receives a Complete Response Letter Regarding the NDA for OX124, a High-Dose Naloxone Rescue Medication in Development for Opioid Overdose

Orexo received a complete response letter from the FDA for OX124, a high-dose naloxone rescue medication for opioid overdose, requiring an additional Human Factors study and technical data on the final commercial product. Orexo plans to address these requests and resubmit the NDA.