25 September 2018 - Neurelis today announced that the company has submitted a new drug application with the U.S. FDA for Valtoco (diazepam nasal spray) as a treatment for epilepsy patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures. 

 Earlier this year, the FDA provided conditional acceptance for use of the name "Valtoco" for the product previously referred to in clinical development as "NRL-1.

The application for Valtoco is supported by an extensive clinical and pre-clinical package including studies in healthy volunteers and patients with epilepsy. In the patient studies, more than 1,600 seizures have been treated to date with Valtoco nasal spray.

Read Neurelis press release