DIACOMIT is the only FDA-approved antiseizure medication specifically for seizures associated with Dravet syndrome in children as young as 6 months. It is indicated for patients weighing 15 pounds or more and taking clobazam.
DIACOMIT® (stiripentol) is an FDA-approved antiseizure medication developed specifically for seizures associated with Dravet syndrome in children as young as 6 months (weighing 15 pounds or more) and taking clobazam. There are no clinical data to support the use of DIACOMIT alone to treat Dravet syndrome.1
DIACOMIT is a unique antiseizure medication that was developed by Biocodex in the 1990s. It is thought to work by reducing abnormal excitement activities in the brain and by making clobazam last longer.1,38,50 Your child’s doctor may recognize or refer to DIACOMIT by its generic name, stiripentol. That’s because DIACOMIT was referred to as stiripentol when it was approved for
compassionate use in the United States in 2000.
In 2018, DIACOMIT was granted FDA approval for children 2 years and older, and in 2022, DIACOMIT’s indication was expanded to include children as young as 6 months weighing 15 pounds or more.1,9,10,15
Treat Seizures Sooner
Most children with Dravet experience their first seizure by 6 months old.49 Before 2022, children under age 2 did not have a Dravet-specific treatment option. Now, you don’t have to wait!
DIACOMIT is the only FDA-approved antiseizure medication for seizures associated with Dravet syndrome in children as young as 6 months.*1
* Weighing 15 lb or more and taking clobazam
Achieve Profound Seizure Reduction
DIACOMIT has clinically demonstrated efficacy in managing seizures associated with Dravet syndrome and is proven to control clonic and tonic-clonic seizures.1,2,16
Review the study results below.
Results may vary.
Trust in Proven Experience
DIACOMIT has nearly three decades of real-world use.7,36,37,51 As of 2022, Biocodex has made it available to patients with Dravet syndrome in more than 35 countries.40
Choose from Two Convenient Forms
DIACOMIT is available in capsules or powder for oral suspension. The oral suspension may be helpful for those who cannot swallow capsules. Both forms can be stored at room temperature (68°F to 77°F), making it easy for you to take on the go!
Read more on Starting DIACOMIT.
It can be nerve-wracking to change your child’s treatment plan, but if you’re not seeing the results you want, it’s okay to ask for less: less frequent seizures, less time at the hospital, less hassle with insurance companies. When it comes to Dravet syndrome, don’t settle for more.
“The demonstrated efficacy of these ‘DS-specific’ medications strongly supports their use earlier in the treatment paradigm…we should redefine our expectations of seizure control, and no longer accept seizures every 1 to 2 months as the best we can do.”53
International Consensus on Diagnosis and Management of Dravet Syndrome (2022)
Review talking points to help you start the conversation about DIACOMIT with your child’s doctor. Your child deserves a Dravet-specific antiseizure treatment.
randomized, placebo-controlled clinical trials, patients with Dravet syndrome on DIACOMIT experienced significantly fewer clonic or tonic-clonic seizures than those on placebo.1,2 About 74% of patients experienced a 50% or greater reduction in seizures in the second month of the study compared with before treatment. More than half of patients experienced a 75% or greater reduction in seizures, with nearly 39% of patients becoming seizure-free during the two-month study period.1,2,6
Main Objective: Responder Rate*
*Response was defined as experiencing a greater than 50% decrease in the frequency of generalized clonic or tonic-clonic seizures.
During the studies, the most common side effects, occurring in 10% or more of patients on DIACOMIT and more frequently than placebo, were:1
Across five other studies, side effects in children with Dravet syndrome who were 6 months to less than 2 years of age were similar to those seen in the pivotal studies. Stiripentol has been studied for more than three decades, resulting in data that support a track record of safety.7,36,37,51
Most side effects of DIACOMIT are predictable and manageable. For example, if your child is feeling more tired or less hungry than usual, talk to their doctor. Your child’s doctor may decide to adjust the dose of certain comedications. Visit Starting DIACOMIT to read more.
DIACOMIT (stiripentol) was tested in two clinical trials, STICLO France and STICLO Italy. In both studies, patients were randomly split into two groups: one group on stiripentol (with clobazam and valproate) and one group on placebo (with clobazam and valproate).1,5
Together, the studies included 56 patients with Dravet syndrome from 3 to 18 years old with inadequately controlled seizures. Researchers measured the response to treatment, or how many patients experienced a 50% or greater reduction in seizures in the second month of the treatment period.6,7 Including both studies, 74% of patients experienced a 50% or more reduction in generalized clonic or tonic-clonic seizures in the second month compared with baseline and nearly 39% of patients became seizure-free for at least eight weeks.1,5,6