Orexo AB has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication intended for opioid overdose. The NDA was initially submitted on September 18, 2023.
The CRL specifies the need for an additional Human Factors (HF) study, aligning with prior communications, and requests supplementary technical data pertaining to the final commercial product. Importantly, the FDA has not requested any additional clinical or non-clinical studies.
Addressing FDA Concerns
In response to feedback received in April 2024, Orexo has been actively optimizing the instructions for use. A new HF study has been successfully completed to meet FDA requirements. The request for additional technical data from final commercial-scale manufacturing was unexpected, but Orexo is working with the FDA to address this issue and resubmit the NDA as quickly as possible. The resubmission will trigger a review period lasting up to six months.
Nikolaj Sørensen, President and CEO of Orexo, stated, "I am impressed by the vigour and agility of the teams in Sweden and the US in addressing FDA’s concerns from April regarding the instructions for use and our ability to complete a new human factors study shortly. However, I am surprised with the agency’s other requests with regards to additional technical data from final commercial product, but I am confident we can address this efficiently."
OX124: Addressing the Opioid Overdose Crisis
OX124 is designed to address the increasing need for more potent naloxone formulations to combat overdoses involving synthetic opioids, such as fentanyl, which are responsible for 92% of all fatal opioid overdoses. OX124 is a proprietary, high-dose naloxone formulation engineered for rapid absorption and high bioavailability, aiming to effectively reverse overdoses or sustain consciousness in patients who have ingested synthetic opioids.
Orexo, a Swedish pharmaceutical company with over 25 years of experience, focuses on developing improved pharmaceuticals using proprietary formulation technologies to address significant medical needs. The company provides innovative treatment solutions for opioid use disorder and related diseases in the U.S. In 2023, Orexo reported total net sales of SEK 639 million and has 116 employees.
