New Drug Application Filed for Diazepam Nasal Spray—an Investigational Treatment for Acute Repetitive Seizures
A new drug application has been filed with the Food and Drug Administration (FDA) for diazepam nasal spray (Valtoco; Neurelis, San Diego, CA), which is being investigated as a treatment for patients age 6 years and up with epilepsy who have acute repetitive seizures (ARS, also known as cluster seizures). Diazepam is 1 of 2 nasal spray formulations of antiepileptic drugs in development for patients with ARS.
This formulation of diazepam incorporates a vitamin-E based solution and alkylsaccharide transmucosal absorption enhancers (Intravail; Aegis, San Diego, CA) for rapid delivery of diazepam through the nasal mucosa. The FDA has previously been granted orphan-drug and fast-track designations.
The new drug application is supported by an extensive clinical and preclinical studies in people with and without epilepsy and includes successful treatment of over 1,600 seizures. More than 1,600 seizures have been treated and thre formulation has demonstrated high bioavailability and low dose-to-dose variability.
Approximately 30% of patients with epilepsy continue to have seizures despite best practice medical management and of these patients, approximately 170,000 have ARS. The only rescue therapy currently available for them is rectally-administered diazepam. Having more options for administration of rescue treatment will benefit patients who experience ARS.
"Cluster or acute repetitive seizures are both dangerous and highly disruptive in the lives of epilepsy patients," said Neurelis President and CEO Craig Chambliss." Valtoco was developed to provide an effective combination of reliability, safety, and tolerability in a simple, ready-to-use nasal spray. Neurelis is passionately focused on providing this important product for epilepsy patients who may benefit from having an on-hand seizure rescue treatment."