September 20, 2021 – Neurelis, Inc. issued an announcement, which is summarized as follows：
Neurelis, Inc. announced today that it has initiated a clinical program to investigate the use of VALTOCO (diazepam nasal spray) in children with epilepsy aged two to five as a treatment for seizure clusters. VALTOCO is currently approved by the U.S. Food and Drug Administration (FDA) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters or acute repetitive seizures) that are distinct from an individual’s usual seizure pattern in patients with epilepsy 6 years of age and older. Safety and effectiveness of VALTOCO in pediatric patients below the age of 6 have not been established.
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs at Neurelis, said there is a “high unmet need” in the two to five-year-old age group for an alternative treatment. “Currently the only FDA-approved option for these children is a rectally administered version of diazepam,” Dr. Rabinowicz said. “We understand that caregivers and physicians treating these younger seizure cluster patients could benefit from having a more convenient, nasally-administered rescue therapy that can be used on the go.”
Sunita Misra, M.D., Ph.D., Neurelis Medical Director, said the clinical program, named Stellina, is a Phase 1/2a open-label pharmacokinetics study of VALTOCO with an open-label safety period in pediatric epilepsy patients from two to five years of age. “The goal of this study is to assess the pharmacokinetics of VALTOCO in this age group as well as to assess its safety and tolerability, ” Dr. Misra said.
Further information can be found in the Neurelis’s Press Release：