Complete Response letter from the FDA regarding the NDA for OX 124, a high-dose naloxone rescue medication in development for opioid overdose

The NDA was submitted to the FDA on September 18, 2023. The CRL indicates the need for an additional Human Factors (HF) study, which is in line with previous communication. Furthermore, additional technical data on the final commercial product has been requested. The CRL does not indicate a need for additional clinical or non-clinical studies.

In response to the comments received in April 2024, Orexo has worked intensively to optimize the instructions of use. To meet the FDA requirement, a new HF study has been successfully completed. The requirement from FDA to provide additional technical data was unexpected, and Orexo will now work expeditiously in consultation with the FDA to address this to enable a resubmission of the NDA to FDA as soon as possible. The review period following the resubmission of the NDA will be up to six months.

The type of technical data required by FDA has already been generated from pilot scale manufacturing and the data were included in the NDA. Orexo´s assessment is that the submitted data support approval however, FDA does not agree and has requested data from the established commercial scale manufacturing.

Upon approval OX 124 will meet the growing need for more powerful medications and higher doses of naloxone for reversal of opioid overdoses involving synthetic opioids, such as fentanyl or fentanyl analogues, which today cause 92 percent of all fatal opioid overdoses.