Biocodex’s Diacomit (stiripentol) Receives FDA Approval for Seizures Associated with Dravet Syndrome (DS) in Patients Aged 2 Years or Older

Shots:

• The approval is based on two study STICLO France and STICLO Italy assessing Diacomit vs PBO in patients with Dravet Syndrome aged 2 years of age and older taking clobazam
• STICLO France and STICLO Italy study results: responder rate (71%, 67% vs 5%, 9.1%)
• Diacomit 250mg & 500mg (stiripentol) is an anti-convulsant drug, approved as an adjunctive treatment with clobazam and valproate DS in 27 countries including EU, Canada, Japan in Jan 2007, Dec 2012, Sept 2012 respectively

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