US FDA declines Orexo's high-dose opioid overdose drug OX124 approval, requiring additional studies and commercial product data.

The US FDA declined to approve Orexo AB's high-dose prescription drug for opioid overdose, OX124, requesting an additional Human Factors study and technical data on the final commercial product. Orexo will work with the FDA for a resubmission. OX124, a nasal rescue medication, contains a high dose of naloxone. The FDA previously approved over-the-counter sales of Narcan and RiVive.