Neurelis, Inc., recently announced 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.
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, please visit www.valtoco.com.
For more information, read the full press release here.