OX640 - Emergency treatment of allergic reactions

Short facts  
API Adrenaline
Technology amorphOX®, nasal powder technology
Indication Emergency treatment of allergic reactions
Development phase Expects to perform first explorative human clinical pharmacokinetic study in the second half of 2022.
Expected filing with FDA -
In-house or partnership Currently in-house, partnership will be assessed during the development phase and for commercialization.

Unmet need:

Today, allergic rescue products are needle-based auto injectors that administer adrenaline to reverse life-threatening reactions (anaphylaxis). Whether self-administered or with the help of others, applying needle injections correctly is often intimidating, with the potential loss of precious life-saving minutes. Current solutions are costly and devices must be replaced frequently because adrenaline rapidly degrades during storage.

Our aim:

With decades of no innovation, products like EpiPen dominates the market. Orexo will strive to bring to market a more fast-acting intranasal product, which is key in life-saving situations. Additionally, the single-dose nasal administration is easy to use and easy to teach others and easy to learn for caregivers.

Differentiation:

Built on our amorphOX® platform, OX640’s dry-powder, single-use, intranasal delivery will provide rapid and extensive absorption with the potential of doubling the stability and shelf-life of current solutions. Moreover, OX640 is preservative-free with no sodium metabisulfite or other stability agents currently needed in today’s devices. These preservatives can in itself cause allergic reactions.