FDA grants orphan drug designation to status epilepticus treatment

The US Food and Drug Administration (FDA) has granted orphan drug designation to Crossject's treatment for status epilepticus (epileptic seizure lasting longer than five minutes), ZENEO Midazolam.

ZENEO is a pre-filled, single use device that can reportedly deliver a medical formulation through the skin in only 50 milliseconds. The device's injection parameters are customisable to the viscosity, dosage and injection route of the drug formulation.

Epilepsy is a neurological disorder that affects millions worldwide. There are still a large amount of seizures that result in fatality and rapid treatment initiation is important in the prevention of serious neurological damage and death.

According to the company, ZENEO Midazolam enables the rapid treatment of epileptic seizures, taking effect in an average 1.2 minutes.