FDA Declines to Approve Orexo’s Opioid Overdose Drug, Seeks More Information

In 2022, more than 81,000 Americans died from an opioid overdose. The new drug has a high dose of the opiate-blocker naloxone.

A seizure of tens of thousands of fentanyl pills by the Drug Enforcement Administration's Rocky Mountain Field Division in a photo released on July 1, 2024. DEA

The U.S. Food and Drug Administration (FDA) has rejected Orexo’s application for a new, high-dose drug for reversing opioid overdoses.

Orexo said on July 16 that the FDA issued a complete response letter, seeking an additional “human factors” study and further technical data on its naloxone rescue medication, known as OX124.