FDA Grants Orphan Drug Designation to Investigational Epilepsy Tx

FDA Grants Orphan Drug Designation to Investigational Epilepsy Tx
FDA Grants Orphan Drug Designation to Investigational Epilepsy Tx

Neurelis announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to NRL-1 (intranasal diazepam) for the treatment of epilepsy in pediatric, adolescent, and adult patients who experience acute repetitive seizures.

NRL-1 is being evaluated as a potential treatment alternative in patients who require intermittent use of diazepam to control bouts of acute repetitive seizure activity. It has demonstrated high bioavailability, low dose variability, and tolerable safety profile in clinical trials.

RELATED: Greater Effort Needed to Prevent Epilepsy-Related Deaths

NRL-1 is a proprietary formulation of diazepam delivered via a nasal sprayer.

For more information visit Neurelis.com.


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