| 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.