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News
The FDA has accepted an investigational new drug (IND) application for OX640, a nasal powder form of epinephrine developed by Orexo to treat anaphylaxis. The product aims to overcome the key drawbacks of traditional autoinjectors — needle fear, user errors, and storage issues. A pivotal clinical trial is expected to kick off in Q4 2026, with a new drug application targeted for 2028.
The FDA has accepted Orexo's investigational new drug (IND) application for OX640, a nasally administered epinephrine powder designed to treat anaphylaxis without the need for an injection. Developed using Orexo's proprietary AmorphOX® drug delivery platform, OX640 aims to solve the well-known pain points of current epinephrine autoinjectors — including needle phobia, frequent use errors, and tricky storage requirements.
Clinical data supporting the IND show that OX640 delivers rapid epinephrine absorption with a pharmacokinetic profile comparable to injectable forms, along with good tolerability. Impressively, the powder remained stable for 6 months at 50°C with less than 3% degradation and stayed functional at temperatures as low as –20°C, making it viable across a wide range of real-world environments.
By the Numbers:
Why it matters: Anaphylaxis is a life-threatening emergency where fast, reliable epinephrine delivery is critical — but many patients struggle with autoinjectors due to needle fear or misuse. A needle-free, temperature-stable nasal powder could meaningfully expand access and improve real-world outcomes for patients at risk of severe allergic reactions.
