Orexo updates on OX124, high-dose naloxone for opioid overdose

UPPSALA, Sweden, July 16, 2024 -- Orexo AB (publ.), a Swedish pharmaceutical company, announced receipt of a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for OX124. This high-dose naloxone rescue medication is designed to treat opioid overdoses, particularly those involving synthetic opioids like fentanyl. The NDA was initially submitted on September 18, 2023.

The CRL from the FDA notes the necessity for an additional Human Factors (HF) study, aligning with previous communications. Additionally, more technical data on the final commercial product is required. However, it is important to note that the CRL does not ask for further clinical or non-clinical studies.

After receiving comments in April 2024, Orexo has been diligently optimizing the instructions for use. A new HF study, meeting the FDA's requirements, has been successfully completed. The unexpected request for additional technical data has prompted Orexo to work swiftly with the FDA to resubmit the NDA at the earliest opportunity. The review period after resubmission could extend up to six months.

The FDA's request involves data already generated from pilot-scale manufacturing included in the NDA. Orexo believes this data supports approval, yet the FDA has requested information specifically from established commercial-scale manufacturing.

Nikolaj Sørensen, President and CEO of Orexo, expressed his admiration for the responsiveness of the teams in Sweden and the US in addressing the FDA's concerns about the instructions for use. He also noted the unexpected nature of the additional technical data request but remains confident in addressing it efficiently. Sørensen emphasized the importance of OX124 in combating the rising fatalities from overdoses caused by synthetic opioids, which now account for 92% of all fatal opioid overdoses. He reiterated the team's commitment to providing the FDA with the required information promptly.

Upon approval, OX124 is expected to fulfill the urgent need for more effective medications and higher doses of naloxone to counteract opioid overdoses involving synthetic opioids. This proprietary high-dose naloxone formulation, with rapid absorption and high bioavailability, can reverse overdoses or help sustain consciousness in patients who have ingested synthetic opioids.

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