> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Neurelis NDA for Epilepsy Nasal Spray
- URL: https://www.fdaweb.com/neurelis-nda-for-epilepsy-nasal-spray/
- Published: 2018-09-26T12:00:00.000Z
- Updated: 2026-09-15T00:34:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142453

Neurelis has filed an NDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy in patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures. The proprietary formulation of diazepam incorporates a combination of a vitamin E-based solution and Intravail, an absorption enhancement, according to the company.

  
The submission is supported by data from studies in healthy volunteers and patients with epilepsy. In the patient studies, more than 1,600 seizures have been treated with the nasal spray. In the trials, Valtoco demonstrated “high bioavailability, low variability from dose to dose, and was well-tolerated,” the company says. The agency in 2015 granted Neurelis an orphan drug designation for the product and in 2016 it was granted a fast track designation.