Orexo’s Opioid Overdose Nasal Spray Fails FDA Review for Second Time

1. FDA Rejection: The FDA has rejected Orexo's OX124 (naloxone) nasal spray for opioid overdose rescue for the second time in 15 months.
2. Reason for Rejection: The FDA requested an additional Human Factors (HF) study and additional technical data on the final commercial product.
3. OX124 Details: OX124 is a nasal rescue medication containing a high dose of naloxone, designed to provide rapid absorption for patients experiencing an opioid overdose.
4. Previous Studies: Orexo had submitted the application for OX124 in September 2023, supported by data from a pivotal study in healthy volunteers, which showed faster and higher absorption of naloxone compared to intramuscular dosing.
5. Market Context: Several other drugmakers sell naloxone-based products, including Narcan and RiVive, which are approved for over-the-counter and prescription-free sale respectively.