Neurelis, Inc. announced that the company has submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for VALTOCOTM (diazepam nasal spray) as a treatment for epilepsy patients six years and older who experience increased bouts of seizure activity, also known as cluster or acute repetitive seizures. Earlier this year, the FDA provided conditional acceptance for use of the name “VALTOCO” for the product previously referred to in clinical development as “NRL-1”.
VALTOCO, Neurelis’ lead product candidate, is a proprietary formulation of diazepam incorporating the unique combination of a vitamin E-based solution and Intravail® absorption enhancement. The FDA previously granted Neurelis both Orphan Drug designation for VALTOCO in November of 2015 and Fast Track designation in December of 2016. There are over 3.4 million people with epilepsy in the United States with approximately 200,000 new patients diagnosed each year. Despite the availability of chronic, daily oral medications to control epilepsy, a significant number of these patients continue to experience seizures. Of these uncontrolled patients, about 170,000 are at risk for cluster or acute repetitive seizures.