San Diego, CA – [April 11, 2024] – Neurelis, Inc. will present a poster on VALTOCO? (diazepam nasal spray) for the treatment of episodes of frequent seizure activity (i.e., seizure clusters) in patients with epilepsy ages 6 to 65 years, describing the time to treatment across different subpopulations. ?A second presentation will provide insight into characterization of a repeat-dosing model for preclinical diazepam studies. These findings will be showcased through posters at the 76th Annual Meeting of the American Academy of Neurology (AAN) in Denver from April 13 to 18, offering both in-person attendance and live online participation in a hybrid format.

“These studies represent our continued commitment to improving outcomes for patients with epilepsy,” said Adrian L. Rabinowicz, M.D., Chief Medical Officer. “Our persistent research highlights the efficacy of VALTOCO, and we are delighted to disseminate these additional findings to patients, physicians, and healthcare organizations attending AAN, an event renowned for its rigorous standards.”

• Characterization of a Novel Repeat-dosing Model for Preclinical Diazepam Studies; Poster #001, in Neighborhood 4; Sunday, April 14th from 8:00 AM – 9:00 AM MDT

A novel preclinical repeat-dosing study of diazepam (DZP) in a rat model was conducted to evaluate potential dosing strategies for preclinical in-life efficacy studies. Sustained DZP levels were observed in plasma and brain, akin to human levels, suggesting potential long-acting effects. Brain-to-plasma ratios indicated increased DZP accumulation in the brain with repeat dosing, supporting the suitability of this dosing regimen for in-life efficacy studies in preclinical models.

• Shorter Time to Treatment with Diazepam Nasal Spray Is Associated with Faster Seizure Termination: A Subpopulation Analysis; Poster #001, in Neighborhood 1; Wednesday, April 17th from 8:00 AM – 9:00 AM MDT

This post hoc analysis of a long-term safety study of DZP nasal spray to evaluate seizure cluster patterns following diazepam administration found that faster administration of the medication correlated with quicker resolution of seizure clusters. This association held true across different populations, emphasizing the critical role of prompt seizure recognition and treatment in reducing injury risk and healthcare utilization.

Enrique Carrazana, M.D., Neurelis Senior Vice President, Strategic Initiatives commented, “Our findings underscore the critical necessity acknowledged within the epilepsy community: the pressing demand for safe, dependable, and easily accessible therapies to address the challenges of seizure clusters.”
VALTOCO, a nasal spray for acute treatment of episodes of frequent seizure activity in adult and pediatric patients 6 years of age and older, was approved by the U.S. Food and Drug Administration (FDA) on Jan. 10, 2020.