FDA Approves Diazepam Nasal Spray for Intermittent, Stereotypic Seizure Activity

The diazepam nasal spray was granted 7 years of Orphan Drug Exclusivity by the FDA Office of Orphan Products Development.

Officials with the FDA have approved diazepam nasal spray (Valtoco, Neurelis, Inc.) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a patient’s usual seizure pattern in people with epilepsy age 6 years and older.

In addition, the diazepam nasal spray was granted 7 years of orphan drug exclusivity by the FDA Office of Orphan Products Development, according to Neurelis.

The spray is a proprietary formulation of diazepam that incorporates intravail transmucosal absorption enhancement technology. The innovative technology enables the noninvasive delivery of a broad range of protein, peptide, and small molecule drugs.

The FDA's approval is based on a long-term, repeat dose clinical trial testing the safety and efficacy of diazepam nasal spray. More than 130 patients were enrolled in the trial, and more than 2000 seizures were treated, including patients aged 6 years and older.

The most common adverse reactions reported from the trial were somnolence, headache, and nasal discomfort.


Neurelis Announces FDA approval for seizure rescue treatment VALTOCO® (diazepam nasal spray) that incorporates the science of Intravail® for consistent and reliable absorption [news release]. San Diego, CA; PR Newswire: January 13, 2020. https://prnmedia.prnewswire.com/news-releases/neurelis-announces-fda-approval-for-seizure-rescue-treatment-valtoco-diazepam-nasal-spray-that-incorporates-the-science-of-intravail-for-consistent-and-reliable-absorption-300985345.html. Accessed January 13, 2020.