【Neurelis-Product Diazepam Nasal Spray】Neurelis Announces 16 Poster Presentations At The Annual Meeting Of The American Epilepsy Society

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Neurelis- Product Diazepam Nasal SprayNeurelis Announces 16 Poster Presentations At The Annual Meeting Of The American Epilepsy Society

2nd Dec 2021 – Neurelis, Inc. issued a press release, which is summarized as follows

Neurelis, Inc. will present a collection of 16 posters describing safety, tolerability and effectiveness results observed in trials evaluating VALTOCO® (diazepam nasal spray), and clinical trials designed to evaluate VALTOCO as a potential rescue therapy in patient groups with unmet needs at the annual meeting of the American Epilepsy Society December 3-7 in Chicago.

Enrique Carrazana, M.D., Neurelis Chief Medical Officer, said the long-term clinical study of VALTOCO® covered 4,390 seizure events and provided supportive evidence of 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 said the Subgroup analyses from the long-term Phase 3 safety study of VALTOCO® (diazepam nasal spray) demonstrated favorable safety and tolerability results in children (6-11 years of age), adolescents (12-17 years of age) and adults who experience seizure clusters. In addition, Safety and effectiveness results for VALTOCO remained consistent in subgroups of patients, including subgroups of patients with concomitant clobazam use, epileptic encephalopathies and seasonal allergies/rhinitis.  “Patient and caregiver reporting suggested that VALTOCO was easy to use and rapid to administer during the study,” Dr. Rabinowicz commented. Patients using VALTOCO reported numerical improvements in some quality of life scores in the long-term safety study.

Additional posters to be presented focus on the following:

1、A study-design poster that describes a new open-label pharmacokinetic and safety study evaluating diazepam nasal spray as a potential rescue therapy for seizure clusters in children aged 2 to 5 years. (Neurelis announced the initation of the Phase 1/2a clinical program in September.)

2、Additional analyses from the long-term safety study, including analyses of administration of second doses of diazepam nasal spray within 4 hours of the first dose using a population pharmacokinetic model and descriptive evaluations. Per the VALTOCO prescribing information, a second dose may be given at least 4 hours after the initial dose, if required. The use of a second dose within 4 hours has not been approved by the FDA.

3、A late-breaking presentation describing preliminary results from a survey of school nurses on current practices and experience treating seizure clusters in the school setting (to understand current practices, barriers, and needs for treatment of seizure clusters in a school setting).

Further information can be found in the Neurelis’s Press Releasehttps://www.neurelis.com/neurelis-announces-16-poster-presentations-annual-meeting-american-epilepsy-society