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News
Orexo's OX640, a nasal powder formulation of epinephrine, has received FDA acceptance of its IND application for treating anaphylaxis. The needle-free product aims to tackle the well-known pitfalls of autoinjectors — needle fear, user errors, and tricky storage requirements. Pivotal trials are slated for Q4 2026, with an NDA submission targeted for 2028.
A needle-free nasal epinephrine spray just cleared a major FDA hurdle
Orexo AB has announced that the FDA accepted its Investigational New Drug (IND) application for OX640 — a nasally administered epinephrine powder designed to treat anaphylaxis without a needle. Built on Orexo's proprietary AmorphOX® drug delivery platform, OX640 aims to solve the persistent problems that plague today's autoinjectors: needle phobia, administration errors, and challenging storage conditions.
The IND submission is backed by preclinical data and completed clinical studies showing rapid epinephrine absorption, a strong pharmacokinetic profile, and good tolerability. Notably, OX640 also demonstrated impressive stability across a wide temperature range — a potential advantage for shelf life compared to existing products on the market.
Orexo is actively seeking a commercialization partner and plans to kick off its pivotal clinical program in Q4 2026, with an NDA submission targeted for 2028.
By the Numbers
Why it matters: Anaphylaxis is a life-threatening emergency where every second counts — and current epinephrine autoinjectors come with real-world barriers. A needle-free, temperature-stable nasal option could meaningfully improve access, ease of use, and outcomes for patients at risk of severe allergic reactions.
