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Valerie DeBenedette is managing editor of Drug Topics.
Diacomit (stiripentol) is indicated for rare, severe form of pediatric epilepsy.
US Bioservices has been chosen by Biocodex SAS to exclusively dispense Diacomit (stiripentol). The drug was approved by the FDA in August 2018 to treat seizures associated with Dravet syndrome in patients two years of age and older taking Clobazam. US Bioservices is part of AmerisourceBergen.
Dravet syndrome is an orphan disease and is one of the most intractable forms of epilepsy. A child with Dravet syndrome usually experiences the first seizures before age one. The condition is characterized by severe epilepsy, developmental disabilities, and a high mortality rate that may be up to 21%. DS is believed to affect about 2,800 patients aged 2 to18 years in the United States.
Stiripentol is used in addition to clobazam. The treatment addresses key unmet medical needs in this poorly serviced population experiencing a catastrophic, life-threatening condition, according to a statement by US Bioservices.
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"US Bioservices is proud to partner with Biocodex to bring this innovative treatment to patients affected by Dravet syndrome,” said Angela Ward, President of US Bioservices. “Because of our unmatched experience in rare disease, we understand the clinical expertise and coordination required to support the specialized needs of patients and their caregivers. We welcome the opportunity to facilitate access to treatment and provide clinically-coordinated care for patients who are prescribed DIACOMIT.”
Stiripentol is approved by the FDA in two formulations, capsules and a powder for suspension in water. The dosage is based on body weight. The most common adverse effects reported with stiripentol are sleepiness and drowsiness, decreased appetite and weight loss, neutropenia and thrombocytopenia, and suicidal agitation, according to the package insert.