Orexo Receives Complete Response Letter for OX124 NDA, High-Dose Naloxone for Opioid Overdose

Uppsala, Sweden – July 16, 2024 – Orexo AB (publ.), (STO:ORX) (OTCQX:ORXOY), has announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) concerning the New Drug Application (NDA) for OX124. OX124 is a high-dose naloxone rescue medication designed for opioid overdose. The NDA was initially submitted on September 18, 2023. The FDA's CRL specifies the requirement for an additional Human Factors (HF) study and additional technical data on the final commercial product. However, it does not necessitate further clinical or non-clinical studies.

After receiving feedback in April 2024, Orexo has been working diligently to enhance the instructions for use of OX124. A new HF study has been completed to meet the FDA's requirements. The request for additional technical data was unexpected, and Orexo is now collaborating closely with the FDA to address this issue promptly. The company aims to resubmit the NDA as soon as possible, and the subsequent review period will be up to six months.

The type of technical data the FDA has requested has already been produced during pilot-scale manufacturing and was included in the initial NDA submission. Orexo believes that this data supports the approval of OX124, but the FDA has asked for data from the established commercial-scale manufacturing.

Nikolaj Sørensen, President and CEO of Orexo, expressed his admiration for the teams in Sweden and the US for their efforts in addressing the FDA's concerns from April regarding the instructions for use. He noted the team's ability to complete a new HF study swiftly. However, Sørensen also expressed surprise at the FDA's request for additional technical data from the final commercial product. He remains confident that these requirements can be efficiently addressed. Sørensen emphasized the importance of OX124 in reducing the number of opioid overdose deaths in the US, particularly those caused by synthetic opioids like fentanyl and its analogues. He and his team are committed to providing the FDA with the additional necessary information as quickly as possible.

Upon approval, OX124 will address the increasing need for more potent medications and higher doses of naloxone to reverse opioid overdoses involving synthetic opioids such as fentanyl, which currently account for 92 percent of all fatal opioid overdoses. OX124's formulation ensures rapid absorption and high bioavailability, which can effectively reverse an overdose or sustain consciousness in patients who have ingested synthetic opioids.

Orexo is a Swedish pharmaceutical company with over 25 years of experience in developing improved pharmaceuticals based on proprietary formulation technologies that meet significant medical needs. In the US market, Orexo offers innovative treatment solutions for patients suffering from opioid use disorder and related diseases. The company also develops and commercializes products targeting other therapeutic areas globally with leading partners. In 2023, Orexo's total net sales amounted to SEK 639 million, and the company employed 116 people. Orexo is listed on Nasdaq Stockholm's main list and is also available as an American Depositary Receipt (ADR) on OTCQX (ORXOY) in the US.