23 August 2018 - Biacodex is pleased to announce that on 20 August 2018, the FDA has approved Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam. 

Diacomit is expected to be available in U.S. pharmacies in early January 2019.

The FDA approval of Diacomit was based on two multicenter placebo-controlled trials similar in terms of disease characteristics and prior treatment of patients, STICLO France and STICLO Italy. The primary efficacy endpoint in both trials was the responder rate, with a responder defined as a patient who experienced a greater than 50% decrease in the frequency (per 30 days) of generalised clonic or tonic-clonic seizures during the double-blind treatment period compared to the 4-week baseline period. 

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