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FDA Approves Diacomit for Treatment of Seizures

Biocodex news release; 2018 Aug 23

The US Food and Drug Administration (FDA) recently approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients aged ≥2 years taking clobazam. Diacomit is expected to be available in US pharmacies in early January 2019. It is manufactured by Biocodex, which is headquartered in Gentilly, France, with an American subsidy in Redwood City, CA.

Dosage/administration: Dosage is 50 mg/kg/day, administered by mouth in 2

or 3 divided doses. Reduce dose or discontinue dose gradually. Capsules must be swallowed whole with a glass of water during a meal and should not be broken or opened. Powder for suspension should be mixed in a glass of water and should be taken immediately after mixing during a meal.

Adverse effects: Adverse reactions that occurred in at least 10% of Diacomit-treated

patients and more frequently than on placebo were somnolence, decreased appetite, agitation, ataxia, weight decreased, hypotonia, nausea, tremor, dysarthria, and insomnia.

Citation:

FDA approves Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam. [news release]. Gentilly, France: Biocodex. August 23, 2018. https://www.prnewswire.com/news-releases/fda-approves-diacomit-stiripentol-for-the-treatment-of-seizures-associated-with-dravet-syndrome-ds-in-patients-2-years-of-age-and-older-taking-clobazam-300701663.html. Accessed September 7, 2018.

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FDA Approves Diacomit for Treatment of Seizures, Biocodex news release; 2018 Aug 23