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# FDA grants orphan drug designation to status epilepticus treatment
- URL: https://www.pharmamanufacturingiq.com/fda-grants-orphan-drug-designation-to-zeneo-midazolam/
- Published: 2018-04-04T16:50:41.000Z
- Updated: 2026-10-08T12:40:19.000Z
- Description: 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.
- Author: PharmaManufacturing IQ Staff
- Tags: Drug Development & Approvals, News, Drug Delivery

***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.***

## Epilepsy ribbon

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](http://www.datapressepremium.com/rmdiff/2010662/PressreleaseCrossjectFDA.pdf?ref=pharmamanufacturingiq.com), ZENEO Midazolam enables the rapid treatment of epileptic seizures, taking effect in an average 1.2 minutes.