What type of epilepsy is Diacomit used to treat?

Diacomit (stiripentol) is an oral anticonvulsant used with clobazam (Onfi) for seizures associated with Dravet syndrome in patients 6 months of age and older, weighing at least 7 kg (15.4 lbs), and taking the benzodiazepine clobazam (Onfi). Diacomit is not used alone to treat Dravet Syndrome, a rare, genetic form of epilepsy. It usually begins in infancy, often during a fever due to illness or vaccination.

Key Points

• Diacomit (stiripentol) is an oral anticonvulsant used for seizures associated with Dravet syndrome in patients 6 months of age and older, weighing 7 kg (15.4 lbs) or more, and taking the benzodiazepine clobazam (Onfi). Diacomit is not used alone to treat Dravet Syndrome.
• Dravet syndrome is a rare, genetic form of epilepsy. It usually begins in infancy, often during a fever due to illness or vaccination. After the first seizure, the seizures tend to worsen in severity and become unpredictable, frequent and difficult to control.
• Diacomit is a treatment option for seizures that are often resistant to other antiseizure (anticonvulsant) medications. It is given as an oral capsule you swallow whole or as an oral suspension. Your doctor will tell you how much to take.

Children with Dravet syndrome can have poor language and motor skills development, hyperactivity, sleep disturbances (insomnia), and difficulty relating to others.

Most patients with Dravet syndrome have a mutation of the SCN1a gene which lowers the brain’s ability to control electrical impulses within the brain.

How effective is Diacomit for Dravet Syndrome?

The effectiveness of Diacomit for Dravet Syndrome was determined in two clinical studies with 64 patients total.

Enrolled patients were between 3 years and under 18 years with Dravet syndrome that was inadequately controlled with clobazam and valproate, and experienced at least 4 generalized clonic or tonic-clonic seizures per month.

In studies, the primary endpoint was the responder rate, defined as greater than a 50% reduction in seizures (per 30 days). In both studies, this endpoint was met in 71% and 67% of patients in the Diacomit group, compared to 5% and 9.1% of patients in the placebo group, respectively, a statistically significant effect.

In addition, 43% and 25% of patients reported no generalized clonic or tonic-clonic seizure for
the duration of the study.

The effectiveness of Diacomit in patients 6 months of age to less than 3 years of age was extrapolated from the 2 studies in patients 3 years to less than 18 years of age.

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What are the side effects of Diacomit?

In trials assessing safety, common side effects that occurred in at least 10% of patients who received Diacomit included:

• drowsiness (somnolence) - 67%
• decreased appetite - 45%
• agitation - 27%
• loss of control of body movements (ataxia) - 27%
• decreased weight - 27%
• low muscle tone or muscle weakness (hypotonia) - 24%
• nausea - 15%
  tremor - 15%
• trouble sleeping (insomnia) - 12%
• trouble saying words clearly (dysarthria) - 12%

More serious side effects may include suicidal thoughts or actions, depression, aggression, and panic attacks.

Which medicines are used to treat Dravet Syndrome?

Medications for Dravet syndrome are best used in a stepwise approach with close follow-up of patients, maximizing effects and dose.

• Clobazam (Onfi) and valproic acid (Depakote, Depakene) are often selected as first-line agents for treatment of Dravet Syndrome. Other therapies that may be used include topiramate (Topamax), levetiracetam (Keppra), and cannabidiol (Epidiolex).
• Diacomit (stiripentol) is an oral anticonvulsant used for seizures associated with Dravet syndrome in patients 2 years of age and older. Diacomit is used with clobazam (Onfi), a benzodiazepine. It comes as capsules or in a packet as a powder for oral suspension.
• Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from marijuana -- cannabidiol (CBD) -- and was the first approved treatment for Dravet syndrome. Epidiolex is available as an oral solution for patients two years and older.
• Fintepla (fenfluramine) is used to treat the seizures associated with Dravet syndrome in patients 2 years of age and older. Fintepla is given orally and comes as a cherry flavored liquid that may be taken with or without food.

This is not all the information you need to know about Diacomit (stiripentol) for safe and effective use. Review the full Diacomit information here, and discuss this information and any questions you have with your doctor or other health care provider.

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