September 29, 2021 – Neurelis, Inc. issued an announcement, which is summarized as follows：
Neurelis, Inc. announced today that it is presenting two posters at the 50th Annual Meeting of the Child Neurology Society in Boston from September 29 through October 2.
The first poster presents analyses from a Phase 3, long-term, open-label, repeat-dose safety study showing that VALTOCO® (diazepam nasal spray) demonstrated favorable long-term safety and tolerability results in children (aged 6-11) and adolescents (aged 12-17) who have epilepsy. The second poster presents additional primary safety data and a post-hoc analysis from the same Phase 3 study, showing that 89% of children and adolescent patients with epilepsy used a single dose of VALTOCO within a 24-hour period (after initial dose of VALTOCO was given). VALTOCO was approved in 2020 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.
Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs at Neurelis, said, “Like in the adult population, these analyses provide further evidence that caregivers and physicians treating these younger seizure cluster patients can have confidence using VALTOCO, a convenient, nasally-administered rescue therapy that can be used on the go.”
Further information can be found in the Neurelis’s Press Release：