FDA Declines Approval of Orexo’s Opioid Overdose Drug, Seeks More Information

The U.S. Food and Drug Administration (FDA) has declined Orexo’s application for a new, high-dose drug for reversing opioid overdoses. Orexo announced on Tuesday 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. The Sweden-based pharmaceutical company said the FDA’s request to provide additional technical data was “unexpected” and that it is working with the agency to enable a resubmission. Orexo submitted the new drug application in September 2023. The company said it developed OX124 to be absorbed quickly for “high bioavailability” to reverse the effects of synthetic opioid poisoning....