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.
Highlights
A seizure is a sudden and uncontrolled electrical disturbance in the brain that can cause changes in movement, behavior, feelings, and consciousness [1]
This study showed that a peak concentration of >100 ng/mL was maintained 8 h after the intranasal solution dosing; 71% of the subjects experienced more than one treatment-emergent adverse events (TEAEs), which were mild to moderate in severity and self-limiting
Diazepam has a longer half-life than intranasal midazolam
Summary
A seizure is a sudden and uncontrolled electrical disturbance in the brain that can cause changes in movement, behavior, feelings, and consciousness [1]. Based on the International League Against Epilepsy (ILAE) classification of seizures, which was updated in 2017, seizures can be classified as focal, general, or unknown onset [1]. The difference between these types of seizures is determined by where they originate in the brain. Unknown onset seizures can have tonic-clonic (what is generally recognized as a seizure during which the person loses consciousness or has stiff muscles and jerky movements) or epileptic motor spasms. Clinical trials of Valtoco® will be compared to determine its safety and efficacy Benzodiapeines, such as diazepam, have been approved for the treatment of anxiety, acute alcohol withdrawal, skeletal muscle spasm, and epileptic disorders, such as SE. Benzodiazepines are DEA class IV related to safety, misuse, and abuse potential
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