VALTOCO offers proven safety and tolerability in patients 6+ years of age
VALTOCO was evaluated in clinical trials and found to be generally safe and well tolerated
A 12-month, open-label, repeat-dose safety study of patients 6+ years of age found1,*:
Treatment-related somnolence was reported in 1.8% of patients
Additional findings:
- No clinically relevant changes in respiratory rate were observed
- Treatment-related adverse reactions were mild to moderate
- No discontinuations* or serious adverse events were considered treatment related
*In a clinical study of adults and children 6 years of age and older, 94% of patients received VALTOCO for at least 6 months and 82% for at least 1 year.1
Overall mean sedation levels were low, mild, transient, and not considered clinically relevant2
Most frequent local treatment-related adverse reactions
The safety of VALTOCO is also supported by double-blind, placebo-controlled trials with diazepam rectal gel, using the same age- and weight-based dosing.3,4
- The most frequent adverse reactions from the diazepam rectal gel studies (≥4%) were somnolence, headache, and diarrhea. Adverse events were usually mild or moderate in intensity3
