Needle-free delivery of epinephrine – a new and unique treatment of allergic reactions, incl. anaphylaxis
OX640 is a best-in-class intranasal epinephrine product that has a rapid onset to counteract suspected allergic reactions, such as anaphylaxis, in patients. The powder-based formulation is extremely stable at a wide range of very low to high temperatures, allowing patients to take the medication with them wherever they go.
Epinephrine – unmet medical need
Indication
- Emergency treatment of allergic reactions, incl. anaphylaxis
First-line treatment
- Injectable epinephrine such as intramuscular auto-injectors, e.g. EpiPen®
Drawbacks with adrenaline auto-injectors
- Fear of needles
- Bulky
- Short shelf-life, despite:
- restricted handling and storage
- the use of antioxidants (and chelating agents)
- manufactured under tightly controlled conditions
- overage of API
Desired epinephrine rescue product
- Needle-free
- Convenient and easy-to-carry
- Highly stable – allowing for a more flexible handling and storage
OX640 – based on the AmorphOX® technology
Formulation development provided nasal powders for clinical proof-of-concept
Formulation
- Spray-dried amorphous powder
- Only GRAS excipients
- No antioxidant, no chelating agent and not manufactured under nitrogen or kept from light
Product
- Single-use nasal device
- Protective storage tube
