Diazepam Nasal

Diazepam Nasal is a rescue medication approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of intermittent, stereotypic episodes of frequent seizures. 

Valtoco

Valtoco® is the brand name of diazepam nasal spray, a rescue medication made by Neurelis.

It is approved for use: 

  • For short-term treatment of seizure clusters (also called acute repetitive seizures)  
  • In children 6 years and older and in adults. people  
  • It is not supposed to be taken daily.  
  • It does not take the place of your daily seizure medicine.  
Valtoco diazepam nasal spray
 

Dosing

Recommended Dosing for Valtoco
 

 

Efficacy of Diazepam Nasal

Two randomized, double-blind studies compared Diastat to placebo. The first study enrolled 91 patients (47 children, 44 adults), who received the first dose of Diastat at the onset of an identified seizure episode. Children were given a second dose four hours later whereas adults were dosed four and 12 hours after the first dose. The median seizure frequency for the Diastat treated group was zero seizures per hour, compared to a median seizure frequency of 0.3 seizures per hour for the placebo group (p < 0.0001). In addition, 62% of patients treated with Diastat were seizure-free during the observation period (12 hours for children, 24 hours for adults) compared to 20% of placebo patients.

The second study enrolled 114 patients (53 children, 61 adults). The dose was given at the onset of the identified episode. The median seizure frequency for the Diastat-treated group was zero seizures per 12 hours, compared to 2.0 seizures per 12 hours for the placebo group (p < 0.03). Patients treated with Diastat also had prolonged time-to-next-seizure compared to placebo (p = 0.0072).

Approval of Valtoco was based primarily upon the drugs bioavailability compared to Diastat. In these studies, the systemic exposure (AUC) and maximal peak concentrations (Cmax) of diazepam was similar between Diastat and  Valtoco. Safety of Valtoco in pediatric patients was also confirmed in open-label studies. With regard to how well Valtoco works, both safety and efficacy were established based primarily upon studies done with Diastat.

Diazepam Nasal Contraindications
  • Diastat and Valtoco is contraindicated in patients with a known hypersensitivity to diazepam and in patients with acute narrow angle glaucoma.

Our Mission

The mission of the Epilepsy Foundation is to lead the fight to overcome the challenges of living with epilepsy and to accelerate therapies to stop seizures, find cures, and save lives.

 
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