【Neurelis-Product Diazepam Nasal Spray】Data from novel, exploratory analysis of intermittent valtoco (diazepam nasal spray) civ use indicates more than two-fold increase in mean interval between seizure clusters

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May 5, 2022— Neurelis, Inc., issued a press release, which is summarized as follows:

Neurelis presents two posters at the 2nd North American Epilepsy Congress (NAEC), held virtually May 5-8, 2022.

The first poster presentation introduces an innovative analysis of SEIzure InterVAL data (SEIVAL) in patients receiving intermittent rescue treatment with diazepam nasal spray. This exploratory, post hoc analysis demonstrates increased SEIVAL with intermittent treatment across time. Researchers evaluated SEIVAL during 490-day periods over 12 months. Mean SEIVAL increased significantly from 12.2 days in Period 1 (P<0.01) to 25.7 days among the consistent cohort of patients with SEIVALs in all 4 periods. No effects of age, treatment duration, change in concomitant medications or quality of life were observed.

The second poster summarizes final results on the use of second doses, safety, and retention rate from the completed long-term, open-label, repeat-dose safety study of VALTOCO for the treatment of seizure clusters in patients with epilepsy ages 6 to 65. The final effectiveness data from the Phase 3 safety study of diazepam nasal spray shows that second doses, used as a proxy for effectiveness, were administered within 24 hours of the first dose for only 11.5%. of seizure clusters among patients 6-11 years and 12.9% of seizure clusters in patients 12-65 years. These results further support that diazepam nasal spray provides protection for 24 hours. The safety profile in both age groups was similar to and consistent with use of rectal diazepam. Nasal irritation rates were low and transient, and similar to baseline, and no serious treatment-related adverse events occurred, including respiratory depression. The study retention rate was high (~76%) in both age groups.

Original website Link: https://www.neurelis.com/data-novel-exploratory-analysis-intermittent-valtocor-diazepam-nasal-spray-civ-use-indicates-more