Treatment-Related Adverse Reactions Were Mild-to-Moderate and Transient2,3
In two open-label repeat-dose clinical studies of patients with epilepsy 6 years of age and older (N=190)1
Most frequent local treatment-related adverse reactions
Nasal discomfort | 6% | |
Epistaxis | 3% | |
Nasal congestion | 3% | |
Dysgeusia | 2% |
Data from an open-label, repeat-dose pharmacokinetic study in epilepsy subjects under seizure and normal conditions (Study 04) and a 12-month, open-label, repeat-dose safety study in epilepsy patients (Study 05).4,5
No Discontinuations or Serious Adverse Events Were Considered Treatment Related2,6*
60%
of patients received VALTOCO for at least 6 months and 35% at least 1 year1†
Additional Safety Information
The safety of VALTOCO is also supported by double-blind, placebo-controlled trials with diazepam rectal gel, using the same dosing strategy1,7
*The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort.1
†In clinical studies of adults and children 6 years of age and older.
Safety Outcomes From a Clinical Study
A phase 1, open-label study assessed the pharmacokinetics and safety of VALTOCO in patients (N=57) with epilepsy2,6
Treatment-Emergent Adverse Events (TEAEs) Were Reported Regardless of Causality2
- The most common treatment-related TEAEs, defined as those occurring in ≥2 subjects, were dysgeusia (5.3%), nasopharyngitis (3.5%), and nasal discomfort (3.5%)2,6
- No changes in respiratory rate were observed2,6
- There were no reported TEAEs of somnolence2,6
Data as of October 20, 2019, from an open-label, repeat-dose pharmacokinetic study in epilepsy subjects under seizure and normal conditions (Study 04).4
Safety Outcomes From a Long-term, Repeat-Dose Study
Ongoing phase 3, open-label, long-term, repeat-dose study assessed the safety of VALTOCO in patients (N=132) with epilepsy (Study 05)8
- In subjects with epilepsy 6 to 65 years of age8
- Study design was for 12-month treatment period with extensions permitted8
- Safety of VALTOCO was the primary study objective8
- Treatment-emergent adverse events (TEAEs) were reported regardless of causality8
- The most common treatment-related TEAEs, defined as those occurring in ≥2 subjects, were nasal discomfort (5.3%), headache (3%), epistaxis (2.3%), cough (1.5%), eye irritation (1.5%), lacrimation increased (1.5%), rhinalgia (1.5%), and somnolence (1.5%)8
- High subject retention rate with no treatment-related discontinuations8
- No serious adverse events were considered to be treatment related8
Single Dose Used for Vast Majority of Episodes9
A phase 3, open-label, repeat-dose, safety study in subjects with epilepsy who experience episodes of frequent seizure activity assessed the safety of diazepam after repeat intranasal doses of VALTOCO over a 12-month period3
Percentage of seizure episodes for which a single dose of VALTOCO was used over the course of 24 hours (N=3,914)9


- Ongoing open-label, repeat-dose safety study9
- 177 patients with epilepsy, ages 6 to 65 years of age9
- 3,914 seizure episodes were treated with VALTOCO9
- Exploratory analysis to assess the safety of diazepam. Study did not have prespecified efficacy endpoints9
- 12-month treatment period for each patient5
A second dose may be given at least 4 hours after the initial dose, if required 1
Watch an Exclusive Webinar About VALTOCO
In this exclusive webinar, Neurelis' Senior Director of Medical Science Liaisons discusses important safety information, explains the benefits and administration of VALTOCO® (diazepam nasal spray), and instructs how to prescribe the on-hand seizure rescue treatment.1 VALTOCO is available to your patients, without them ever having to leave their home. View the video to learn more.
