Orexo announced that the FDA will require the company to resubmit its NDA for OX124 intranasal dry powder naloxone due to “unexpected technical issues with the equipment used for the secondary packaging process in the outsourced supply chain for OX124.” The company had announced its submission of the NDA in February 2023. According to Orexo, the agency’s only request is for the company to qualify the process and resubmit the NDA when the equipment is ready for inspection.
According to the announcement, Orexo expects to refile the NDA in the third quarter of this year, which would extend the FDA review into the second half of 2024. As a result of the need to resubmit, the company said, the expected launch for OX124 if approved would be delayed from early 2024 to late 2024.
Other candidates in Orexo’s pipeline include OX125 intranasal nalmefene and OX640 epinephrine nasal powder. The products are all based on the company’s amorphOX particle engineering technology.
Orexo President and CEO Nikolaj Sørensen commented, “As a lifesaving rescue medication OX124 must meet the highest standard of reliability and quality in the manufacturing process. This requires Orexo and our manufacturing partners to scrutinize all aspects of the value chain and any potential issues are assessed in detail before initiating commercial manufacturing. I am disappointed with the delay in the process of bringing this life saving medication to the US market. However, I am pleased the manufacturing team is confident we have a solution to the technical issues in the packaging process and that it has no impact on the chances for final approval. When solved, this will even further strengthen the supply chain for our future rescue medications, such as OX640 and OX125.”
Read the Orexo press release.
