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Objective
Intermittent rescue therapy may be used for seizure clusters, which are clinical emergencies that may persist ≥24 h and increase risk of status epilepticus, emergency room visits, and reduced quality of life for patients with epilepsy. Beyond effectiveness for aborting seizure clusters, no data exist on how intermittent rescue therapy may impact the long‐term natural course of seizure clusters...
Objective
An exploratory analysis from a long‐term, phase 3, open‐label, repeat‐dose safety study of diazepam nasal spray for acute treatment of seizure clusters assessed the use of a second dose up to 24 hours after the initial dose and effectiveness in potentially reducing the number of seizures.
Methods
Seizures and doses were recorded in diaries.
Results
Of 175 patients enrolled, 163 received...
Objective
A Phase 3 open‐label safety study (NCT02721069) evaluated long‐term safety of diazepam nasal spray (Valtoco) in patients with epilepsy and frequent seizure clusters.
Methods
Patients were 6–65 years old with diagnosed epilepsy and seizure clusters despite stable antiseizure medications. The treatment period was 12 months, with study visits at Day 30 and every 60 days thereafter, after...
Objective
Diazepam nasal spray (Valtoco), indicated for acute treatment of frequent seizure activity (seizure clusters) in patients with epilepsy ≥6 years of age, is designed to be a rapid, noninvasive, socially acceptable route of administration. This interim analysis evaluated the safety profile of diazepam nasal spray in patients with and without concomitant use of benzodiazepines, with use of...
Objective
To assess pharmacokinetics and safety of diazepam nasal spray (NRL‐1; VALTOCO®) in pediatric and adult patients with epilepsy in seizure and nonseizure states.
Methods
A single dose of diazepam nasal spray (5, 10, 15, or 20 mg based on weight) was administered during each of two conditions (ictal/peri‐ictal and interictal condition) to patients 6‐65 years old with partial or generalized...
ObjectiveTo determine the feasibility of administering a diazepam nasal spray formulation (diazepam‐NS) to adults with epilepsy during a generalized tonic–clonic seizure or in the postictal period following a tonic–clonic or other seizure type, to assess pharmacokinetics and to assess tolerability.
MethodsAn open‐label study was conducted in patients admitted to the epilepsy monitoring unit. Eligible...
Diazepam rectal gel (RG) is currently the only approved rescue therapy for outpatient management of seizure clusters in the United States. There is an unmet medical need for an alternative rescue therapy for seizure clusters that is effective, and more convenient to administer with a socially acceptable method of delivery. An intranasal diazepam formulation has been developed, and this study evaluates...
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