11/1/2019
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`Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric…
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`Home (/) - Neurelis News (/neurelis-news) -
`Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational
`Treatment For Pediatric, Adolescent And Adult Epilepsy Patients
`
`NEURELIS FILES NEW DRUG APPLICATION WITH THE FDA FOR
`VALTOCO™ (DIAZEPAM NASAL SPRAY), AN INVESTIGATIONAL
`TREATMENT FOR PEDIATRIC, ADOLESCENT AND ADULT EPILEPSY
`PATIENTS
`
` / 24 September 2018 0 Comments (/neurelis-news/neurelis-les-new-drug-application-fda-valtocotm-nasal-spray-/
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`investigational-treatment-pediatric/#comments)
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`SAN DIEGO, CA – Sept. 25, 2018 -- Neurelis, Inc. today announced that the company has
`submitted a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA)
`TM
`for VALTOCO (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 signicant number of these patients continue to experience seizures.  Of
`these uncontrolled patients, about 170,000 are at risk for cluster or acute repetitive seizures.  
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`11/1/2019
`Neurelis Files New Drug Application With The FDA For VALTOCO™ (Diazepam Nasal Spray), An Investigational Treatment For Pediatric…
`“Cluster or acute repetitive seizures are both dangerous and highly disruptive in the lives of
`epilepsy patients,” said Neurelis President and CEO Craig Chambliss. “VALTOCO was
`developed to provide an eective combination of reliability, safety, and tolerability in a simple,
`ready-to-use nasal spray.”
`The NDA for VALTOCO is supported by an extensive clinical and pre-clinical package including
`studies in healthy volunteers and patients with epilepsy.  In the patient studies, more than
`1,600 seizures have been treated to date with VALTOCO nasal spray.  
`This NDA submission also represents a highly meaningful milestone for the Neurelis team,
`many of which have been intimately engaged in advancing epilepsy rescue treatment options
`over the last two decades.  “Neurelis is passionately focused on providing this important
`product for epilepsy patients who may benet from having an on-hand seizure rescue
`treatment that can be administered outside a medical setting,” Chambliss said. “It has been
`more than twenty years since a new therapy has been approved for the treatment of cluster
`or acute seizures.  This lack of novel and innovative therapies is a signicant unmet need in the
`epilepsy community that needs to be addressed.”  
`More About VALTOCO
`VALTOCO nasal spray is a proprietary formulation of diazepam, delivered via a nasal spray
`formulation, developed for the management of pediatric, adolescent, and adult patients who
`require intermittent use of diazepam to control bouts of increased seizure activity, also known
`as cluster or acute repetitive seizures.  In clinical trials, VALTOCO demonstrated high
`bioavailability, low variability from dose to dose, and was well-tolerated.
`About Neurelis
`Neurelis, Inc. is a privately-held San Diego-based specialty pharmaceutical company organized
`to license, develop, and commercialize product candidates for epilepsy and the broader
`central nervous system (CNS) market. Neurelis is leveraging its expertise in the development
`and commercialization of CNS compounds and strong relationships with leading researchers
`and clinicians in these markets to advance unique product candidates, such as VALTOCO, to
`address signicant unmet medical needs.
`
`© Neurelis, Inc. 2019. All rights reserved.
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`Neurelis - EX. 2023
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