Neurelis Announces Five Poster Presentations for the Annual Meeting of The American Academy of Neurology
2021-04-20 11:24

19th April 2021 - Neurelis, Inc. issued an announcement, which is summarized as follows£º

-      Data from clinical studies continue to support effectiveness, tolerability and safety profile for Neurelis¡¯ lead product, VALTOCO® (diazepam nasal spray), the first and only nasal spray treatment for seizure cluster rescue in adult and pediatric patients 6 years of age and older

-      Survey data presented at AAN shows that nearly 80% of patients were comfortable doing activities outside the home when carrying VALTOCO with them

-      Data also show 78.2% of patients were back to their usual selves within two hours after administration of VALTOCO

Enrique Carrazana, M.D., Neurelis Chief Medical Officer, said the clinical study of VALTOCO® (diazepam nasal spray), which covers 4,390 seizure events, continues to demonstrate its safety, effectiveness and tolerability. VALTOCO was approved by the U.S. Food and Drug Administration (FDA) in 2020 for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient¡¯s usual seizure pattern in adult and pediatric patients 6 years of age and older. In granting VALTOCO Orphan Drug Exclusivity, the FDA recognized VALTOCO¡¯s intranasal route of administration as clinically superior to the previously approved standard of care treatment (DIASTAT®, a rectal gel formulation of diazepam).

Adrian L. Rabinowicz, M.D., Senior Vice President of Clinical Development and Medical Affairs, commented, ¡°Seizure clusters can have a dramatic impact on a patient and caregiver¡¯s life. These data presented at AAN show that VALTOCO can help patients feel more confident about resuming their normal activity outside the home without concerns over privacy and ease-of-use they may have experienced in the past with rectally administered medication. In addition, the data shows that patients reported feeling like their usual self within two hours after VALTOCO administration. To be able to continue on with your day is very meaningful for patients with seizure clusters.¡±

Abstract: Safety Profile of Valtoco®(diazepam nasal spray) in Patients With Epilepsy: Final Results From a Phase 3, Open-Label, 12-Month Repeat Dose Safety Study

Abstract: Time to Second Doses in Emergency Seizure Patients Treated With Valtoco® (diazepam nasal spray) Across 24 Hours: Subgroup Results From a Completed Phase 3, Open-label, Repeat Dose Safety Study

Abstract: Exploring the Impact of Need for a Second Dose of Rescue Therapy for Seizure Episodes on Healthcare Utilization

Abstract: Evaluation of Diazepam Nasal Spray in Patients with Epilepsy Concomitantly Using Maintenance Benzodiazepines: Interim Analysis from a Phase 3, Long-term, Open-label Safety Study

Abstract: Examining the Patient Experience With Diazepam Nasal Spray for Seizure Clusters: Patient-reported Results From an Exit Survey of a Phase 3, Open-label, Repeat Dose Safety Study

The original website link£º