Posted by Michael Wonder on 13 Jan 2020
Neurelis announces FDA approval for seizure rescue treatment Valtoco (diazepam nasal spray) that incorporates the science of Intravail for consistent and reliable absoption
13 January 2020 - Valtoco is the first nasal spray approved by the FDA as a rescue treatment for people with epilepsy aged 6 and older.
Neurelis today announced that the U.S. FDA has approved Valtoco (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient’s usual seizure pattern in people with epilepsy 6 years of age and older. The unique formulation of Valtoco incorporates Intravail for consistent and reliable absorption.
Valtoco was also granted seven years of orphan drug exclusivity by the FDA Office of Orphan Products Development.
