FDA approves Valtoco for frequent seizure activity in epilepsy.- Neurelis

Neurelis announced that the 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.

In a long-term, open-label, repeat dose, clinical trial, the safety of Valtoco was evaluated: over 130 patients were enrolled and more than 2,000 seizures were treated. The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. The clinical trial included patients aged 6 and above. Until recently, approved treatment outside of medical care settings was only available as a rectally administered medication.