FDA Approves First Nasal Seizure Rescue Medication for Ages 6 and Above



The U.S. Food and Drug Administration (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.

VALTOCO is a proprietary formulation of diazepam incorporating Intravail®, a proprietary transmucosal absorption enhancer. Despite the availability of chronic, daily oral medications to control epilepsy, it is estimated that 170,000 individuals in the United States are at risk for cluster or acute repetitive seizures. 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.

Previously, diazepam was only approved by the FDA in a rectal gel formulation. The availability of an intranasal formulation of diazepam provides a new on-hand rescue treatment option for patients and their care partners that can be used outside of the medical setting - wherever and whenever they need it.

In conjunction with the FDA approval of VALTOCO, Neurelis has launched a patient service program, myNEURELIS™ (1-866-696-3873). myNEURELIS is designed as a flexible program, which allows patients and care partners to personally select their desired support services. For more information on VALTOCO, you can visit www.valtoco.com. For more information on Neurelis, please visit www.neurelis.com.