Neurelis Announces Five Poster Presentations for the Annual Meeting of The American Academy of Neurology

Partner News

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

–      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

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