The Food and Drug Administration (FDA) has expanded the approval of Diacomit® (stiripentol) to include patients 6 months of age and older, weighing 7kg or more, with seizures associated with Dravet syndrome who are taking clobazam. Previously, the treatment had been approved for patients 2 years of age and older.
The effectiveness of Diacomit in patients 6 months of age to less than 3 years of age was extrapolated from the demonstration of effectiveness in patients 3 years to less than 18 years of age in 2 multicenter, placebo-controlled, double-blind, randomized clinical studies. Adverse reactions in pediatric patients 6 months to less than 2 years were found to be similar to those seen in previous clinical studies.
The most common adverse reactions associated with Diacomit are somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, and insomnia.
Diacomit is supplied as 250mg and 500mg strength capsules in 60-count bottles and as fruit-flavored powder packets for oral suspension in 60-count cartons.
“Biocodex is committed to supporting patients with Dravet syndrome and their caregivers,” said Nicolas Coudurier, Biocodex’s CEO. “We are thrilled to positively impact more children’s lives by providing access to specialized, effective treatment closer to the time of their Dravet syndrome diagnosis.”
- Antiseizure drug Diacomit now approved for children as young as 6 months. News release. Biocodex, Inc. Accessed September 21, 2022. https://www.prnewswire.com/news-releases/antiseizure-drug-diacomit-now-approved-for-children-as-young-as-6-months-301628988.html
- Diacomit. Package insert. Biocodex, Inc.; 2022. Accessed September 21, 2022. https://www.diacomit.com/downloads/pdf/DIACOMIT_US_PI.pdf