VALTOCO® (Diazepam Nasal Spray) for the Acute Treatment of Intermittent Stereotypic Episodes of Frequent Seizure Activity

Abstract

Valtoco® is a new FDA-approved nasal spray version of diazepam indicated for the treatment of acute, intermittent, and stereotypic episodes of frequent seizure activity in epilepsy patients six years of age and older. Although IV and rectal diazepam are already used to treat seizure clusters, Valtoco® has less variability in plasma concentration compared to rectal diazepam. Furthermore, the intranasal administration of Valtoco® is more convenient and less invasive than rectal or IV diazepam, making it ideal for self-administration outside of a hospital setting. Multiple clinical trials have taken place comparing Valtoco® to the oral, rectal, and IV forms of diazepam. Aside from mild nasal irritation and lacrimation, Valtoco® was found to have no increased safety risk in comparison to traditional forms of diazepam. This review of Valtoco® will include a history of diazepam prescribing and withdrawal treatment, Valtoco® drug information, its mechanism of action, pharmacokinetics and pharmacodynamics, and a comprehensive review of clinical studies.

Current summary of the evidence in drone-based emergency medical services care

“…Administration of benzodiazepines by family and bystanders has historically been hindered by route of administration as, until recently, the only FDA-approved medication utilized a rectal route of administration. 70 , 71 , 72 While the development of alternative administration routes and formulations 73 , 74 , 75 , 76 , 77 , 78 , 79 has begun to mitigate these concerns, lack of access to benzodiazepines in the out-of-hospital setting, similarly to AEDs and naloxone, remains a barrier.…”

New Pharmacological Therapies in the Treatment of Epilepsy in the Pediatric Population

“…However, adverse effects related to administration such as fever (17.9%) and upper respiratory tract infection (17.9%) were reported most frequently, with nosebleeds (2.6%) reported less frequently [ 40 ]. Diazepam intranasally should be used from 6 years of age up to 11 years of age; the dose is 0.3 mg/kg, with 0.2 mg/kg above 12 years of age [ 41 , 42 ].…”

Intranasal Polymeric and Lipid-Based Nanocarriers for CNS Drug Delivery

“…Not only does this affect a patient’s quality of life, but it also reduces therapeutic adherence. Nasal spray formulations of commonly used AEDs, such as diazepam and midazolam, have recently been FDA-approved for clinical use [ 137 , 138 ]. Data collected during various clinical trials suggests that both intranasal formulations have improved patient quality of life, are safe for use by children and adolescents, and they are effective at the cessation of seizure clusters and of acute seizures compared to alternative administration routes [ 139 , 140 , 141 , 142 ].…”