FDA approves Diacomit to treat seizures associated with Dravet syndrome .- Biocodex.

The FDA has approved Diacomit (stiripentol) from Biocodex for the treatment of seizures associated with Dravet syndrome in patients aged greater than 2 years taking clobazam. Diacomit was evaluated in 2 multicenter, placebo-controlled, double-blind, randomized studies (Study 1 and Study 2). Eligible patients were aged 3 years to <18 years with dravet syndrome and had to be inadequately controlled on clobazam and valproate. after a 1-month baseline period patients were randomized to either diacomit or placebo in addition to their treatment with clobazam and valproate.>

The primary efficacy endpoint for both studies was the rate of responders, defined as a patient who had ?50% decrease in the frequency (per 30 days) of generalized clonic or tonic-clonic seizures during the double-blind treatment period vs the 1-month baseline period. In Study 1 (N=41), 71% of Diacomit-treated patients were responders vs 5% in the placebo group (P <.0001), while in study 2 n="23)," 67 of diacomit-treated patients were responders vs 9.1 in the placebo arm p><.0094). treatment with diacomit was also superior to placebo for the reduction in mean frequency of generalized clonic or tonic-clonic seizures.>