Orexo AB has announced positive data from a pre-clinical in vivo study on the nasal absorption of atipamezole when delivered with Orexo’s AmorphOX® drug delivery technology.
The study results mark an important milestone in the development of OX390, an emergency treatment to reverse overdoses involving xylazine and medetomidine, alpha-2 agonists often referred to as ‘Tranq’ and ‘Rhino Tranq’ respectively.
The study demonstrated rapid and substantial intranasal absorption of atipamezole, successfully establishing proof-of-concept across multiple formulations.
The results support that a single nasal dose of OX390 achieves exposure within the targeted therapeutic range. The next milestone in the project is an upcoming type C meeting with the FDA to agree on the non-clinical development plan that will enable human clinical trials.
Ed Kim, Chief Medical Officer of Orexo, said: ‘OX390 is a potentially life-saving treatment and likely to be the world’s first medical countermeasure (MCM) to the rising threat from xylazine and medetomidine. With the robust results from the in-vivo study we will proceed with the development of OX390 with strong confidence in OX390’s viability for nasal delivery of atipamezole. Overdoses involving an alpha-2 agonist is on the rise in the US and is a rapidly evolving threat to public health in the United States. Orexo is leading the development of a highly needed treatment, and we look forward to the next milestone, the type C meeting with FDA.’
This project has been supported in whole or in part with federal funds from the US Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50125C00010.
