Diacomit Approved to Treat Dravet Syndrome
August 21, 2018 – The U.S. FDA has approved Diacomit® (stiripentol), manufactured by Biocodex, to be used in conjunction with clobazam to treat seizures associated with Dravet Syndrome in patients who are at least two years of age. Diacomit is not approved for use as a monotherapy.
Dravet Syndrome, a rare and severe form of epilepsy, affects one out of every 15,700 people worldwide. It typically begins in the first year of life, and is characterized by frequent and prolonged seizures. An estimated 15-20% of patients diagnosed with Dravet Syndrome die due to complications of the disease.
In clinical studies, patients who received Diacomit experienced a 43% reduction in the mean frequency of generalized clonic or tonic-clonic seizures, and 25% of patients reported experiencing no generalized clonic or tonic-clonic seizures for the duration of the study. Recommended dosing is based on the patient’s weight, with doses given two to three times daily. To reduce the risk of increased seizure activity, any reductions in dose or discontinuation of Diacomit should be done gradually.
Biocodex will offer the medication as both an oral capsule and a powder for oral suspension in 250mg and 500mg strengths. The capsules must be swallowed whole, while the powder should be mixed with a glass of water and taken immediately after mixing. Both dosage forms should be taken during a meal.
Launch and pricing plans have not yet been announced.